User manual for electronic applications for access to data at NIPH
Contents
1. Documents that are forwarded later should preferably be submitted by email directly to the named caseworker at NIPH or to datatilgang fhi no The mail should be marked with the content project User manual for electronic application for access to data Page 23 of 29 number and the name of the project If you apply for data from several sources you will have several caseworkers one from each registry It is only necessary to forward the documents to one caseworker at NIPH Additional requirements Application for access to data Main sources Data sources e Project description 1 e Project description 2 e Approvals Additional requirements Principal investigator and billing address e Co workers Attachments Submit application Additional requirements o Has The Regional Committees for Medical and Health Research Ethics in Norway REC approved the use of biological material in the project O Yes O No Will the human biological material be transferred to laboratories outside of Norway for analysis No Yes Other attachments Add file Save and Close Figure 29 Additional requirements AAA The use of human biological materials in research is covered by the Health Research Act and shall be assessed by the Regional Committees for Medical and Health Research Ethics REC If there is a need for genetic testing with diagnostic or therapeutic consequences for the research participant or2. If the project applies for data from other mandatory national health registries or collect their own material please inform about this on the page Data sources outside NIPH Please note that NIPH only handles requests for access to data from the registries they manage User manual for electronic application for access to data Page 15 of 29 Select Health studies at NIPH Application for access to data AAA mb Select the health studies at NIPH the project needs data from by checking for the appropriate study in the list For each health study you will be asked to describe the Main sources Health studies at NIPH o Data sources Please select the NIPH health study the project needs data from e Mandatory national health registries Health studies Human biological material Data sources outside NIPH Project Attachments Submit application The Age 40 Programme Oslo The Age 40 Programme 1985 1999 CONOR Cohort of Norway Height and weight in X ray screenings 1963 1975 HELMILO Health and Environment in Oslo 2009 HUBRO The Oslo Health Study HUSK The Hordaland Health Study The Norwegian Counties Study 1974 85 Norwegian Mother and Child Cohort Study Norwegian Twin Registry NTR OPPHED Health Study Oppland and Hedmark required data se on the following pages NIPH administers a variety of health screenings See here for more info
3. mail When we start processing your application you will receive a new e mail with information about coordinator and proceedings If you have any questions please use the contact information on this page Figure 13 Submitted application User manual for electronic application for access to data Page 13 of 29 When the application has been submitted a confirmation page is opened and a confirmation email is sent to the applicant and the email address listed on the principal investigator page Bekreftelse p innsending av s knad Confirmation message inbox x 5 Folkehelseinstituttet lt do not reply fhi no gt 2 12 PM 0 minutes ago A v to me Dette er en automatisk bekreftelse p at din s knad er mottatt hos FHI Behandling av s knaden starter i l pet av f dager Du vil motta en e post med informasjon om saksbehandler og videre saksgang n r saksbehandling starter Frist for utlevering av materiale starter f rst n r s knaden er godkjent Mer informasjon om saksbehandling og frister finner du her www fhi no forskning 0g data datatilgang Dersom du nsker kontakte oss benytt informasjon p f lgende side www fhi no om fhi nasjonalt folkehelseinstitutt kontaktinformasjon Med vennlig hilsen Nasjonalt folkehelseinstitutt Postboks 4404 Nydalen 0403 Oslo Sentralbord 21 07 70 00 www fhi no This is an automated confirmation that your application has been received at FHI We will start processing the appl
4. AAA information about data from other central sources that project will use including data the project has planned to collect or has already collected For more information about other mandatory national health registries please click the link e Norwegian Armed Forces Health Registry Contact The Norwegian Armed Forces Medical Services e The Cancer Registry e NORM e The Norwegian Patient Registry NPR e The IPLOS Registry You must submit an application to each data manager for access to data from these sources In order to assess the application NIPH needs information about data from other central sources that project will use including data the project has planned to collect or has already collected Note that the project must submit an application to each data manager for access to data from these sources User manual for electronic application for access to data Page 17 of 29 Has the project collected its own data or are there plans for collecting data No Yes Collected data Please describe the research data biological material clinical examination questionnaires etc Collection of own data is planned Please describe the research data biological material clinical examination questionnaires etc If the project plans to collect data or create a sub cohort connected with one of NIPHs Health studies please consult the contact person for the relevant Health study in ad
5. Add lt lt Back A co applicant is a person that is given access to an application A co applicant has full access to edit and submit the application To add co applicant select Add co applicant in the column Actions in the row for the selected application Enter the co applicant email address in the field under the heading Add new co applicant When a co applicant is added an email is sent to this email address with information The co applicant must log on to the application pages with the same email address for accessing the application The application she is given access to is in the list of stored applications with the role co applicant When co applicants are added their email addresses are listed in a table on the application detail page From the table it is possible to delete co applicants Note that co applicants can delete themselves User manual for electronic application for access to data Page 8 of 29 About the application forms The application forms opens in separate windows Both forms follows the Elmer standard for government reporting http www elmer no retningslinjer 2 0 1 1 html They contain a navigation area an input area and an information area see figure below Note that the navigation changes with the choices made by the applicant For example the pages of Describe data set will be available when data source is selected When the user makes changes underlying pages als
6. where it is planned to give information back to the individual research participant the application shall in addition be sendt to the Health Directorate cf The Biotechnology Act Human biological material from a research biobank can only be sent out of Norway after approval from REC The use of human biological materials in research is covered by the Health Research Act and shall be assessed by the Regional Committees for Medical and Health Research Ethics REC If there is a need for genetic testing with diagnostic or therapeutic consequences for the research participant or where it is planned to give information back to the individual research participant the application shall in addition be sent to the Health Directorate cf The Biotechnology Act Human biological material can only be transferred out of Norway if the project has obtained an approval from the Regional Committees for Medical and Health Research Ethics in Norway REC User manual for electronic application for access to data Page 24 of 29 Principal investigator folkehelseinstituttet Application for access to data Main sources Principal investigator and Billing Address Oo Data sources Principal Investigator O Data set Name Project Description E mail nanebetbexhoneems O gmail com Project Description 2 cg Academic degree Approvals Additional Requirements Position Principal investigator and Billing Address Res
7. 4000 characters i The length of the summary Data set should not exceed one page The Popular Science abstract end pe TERS sites e Project Description e Project Description 2 Summary i e Approvals e Additional Requirements e Principal investigator and Billing Address e Co workers F a Project Start dd mm yyyy Attachments Submit application Project End dd mm yyyy e Funding Figure 27 Project description page 2 In addition to the attached research protocol NIPH needs project information for processing the application The length of the summary should not exceed one page The Popular Science abstract will be published in NIPH sites Add a brief synopsis of the research protocol the length corresponding to the abstract The Summary is useful when assessing the application at NIPH Public information should be a popular scientific presentation of the project 3 4 sentences long The presentation the project title and the name of the project will be posted on NIPHs website www fhi no Date of start of the project is the when the project start collecting new data or collation of existing data User manual for electronic application for access to data Page 22 of 29 The date for end of project is the date for publication of results or the completion of a thesis or report Permissions to use the material ceases at the end of the project unless the project applies for an extension Projects must pay a fee for NIPH
8. Add file of congenital abnormalities e Describe the data linkage Project Attachments 3 Submit application Save and Close Figure 21 Describe the data set from a selected Mandatory national health registry Describe how and from what data source the population base should be formed Alternatively state the number of individuals that are required to answer the research question s as well as which variables and period of time Variable Lists For some of the registries and health studies it is possible to upload variable lists created by the applicant in advance There are links to the current variable lists from information text for the User manual for electronic application for access to data Page 18 of 29 variable lists The possibility to upload variable lists are only accessible where the registry has available assets to create lists Nesstar excel sheets etc It is not mandatory to upload variable list but where available it will be helpful for both the applicant and the caseworker Describe the data set from a selected health study folkehelseinstituttet Application for access to data Main sources Data sources oatasee Medical Birth Registry of Norway MBRN HUSK The Hordaland Health Study Norwegian Mother and Child Cohort Study Describe bio material from MoBa Describe the variables Describe the data linkage Project Attachments Submit application Describe the data set
9. access to data AAA Main sources Summa i gt The application is now ready ry to be submitted To see the full application in context please click on the PDF icon Data sources The application is ready to be sent The PDF displays all the field Data set Show PDF names with associated information Project Attachments 7 lt lt Previous Page Submit application ao Submit Application The application is now ready to be submitted To see the full application in context click on the PDF icon The PDF displays all the field names with associated information User manual for electronic application for access to data Page 28 of 29 Submitted application folkehelseinstituttet Thank you Your application has been submitted You will soon receive a confirmation e mail When we start processing your application you will receive a new e mail with information about coordinator and proceedings If you have any questions please use the contact information on this page Close Figure 36 Submitted application When the application has been submitted a confirmation page is opened and a confirmation email is sent to the applicant and the email address listed on the principal investigator page Bekreftelse p innsending av s knad Confirmation message inbox x Folkehelseinstituttet lt do not replyQfhi no 2 12 PM 0 minutes ago mv to me v Dette er en automatisk bekreftelse p at din s knad er mottatt
10. hos FHI Behandling av s knaden starter i l pet av f dager Du vil motta en e post med informasjon om saksbehandler og videre saksgang n r saksbehandling starter Frist for utlevering av materiale starter f rst n r s knaden er godkjent Mer informasjon om saksbehandling og frister finner du her www fhi no forskning 0g data datatilgang Dersom du nsker kontakte oss benytt informasjon p f lgende side www fhi no om fhi nasjonalt folkehelseinstitutt kontaktinformasjon Med vennlig hilsen Nasjonalt folkehelseinstitutt Postboks 4404 Nydalen 0403 Oslo Sentralbord 21 07 70 00 www fhi no This is an automated confirmation that your application has been received at FHI We will start processing the application in a few days You will receive an e mail with information from the case officer and further procedures when processing starts The time limit for delivery of material only begins when the application is approved More information about procedures and deadlines can be found at www fhi no artikler id 69867 If you wish to contact us use the information on the following page www fhi no artikler id 104529 Sincerely Norwegian Institute of Public Health PO Box 4404 N 0403 Oslo Switchboard 47 21 07 70 00 www fhi no Figure 37 Confirmation on email User manual for electronic application for access to data Page 29 of 29
11. to connect to Note that it is not mandatory to describe the data linkage If the field is empty the FHI will disclose the files with a serial number so that the researcher can make the linkage Project description page 1 folkehelseinstituttet Application for access to data AAA Main sources Project Description Oo gt In this section we ask for project information required for efficient proceedings The project title will be made Project Title Gi public on the NIPHs Data set webpages and in our public archives The title will also GE n a pe Project Type Gi v Data sources e Project Description e Project Description 2 Purpose and problem description max 1500 characters 8 e Approvals Additional Requirements Principal investigator and Billing Address e Co workers Problem description max 1500 characters Oo Attachments Submit application Scientific papers planned from this study Keywords use lt a href http www nlm nih gov mesh MBrowser htm target blank gt MESH lt a gt Figure 26 Project description page 1 In this section we ask for project information required for efficient proceedings The project title should be short and descriptive The title will appear in the project list on your NIPH application page and in the equivalent list for co authors The title will also be used as a name in the NIPH public archive and project record User manual for electroni
12. 15 Select Mandatory national health registries at NIPH cc cccccccee cece cesses cesses eee eeeeeneaaaaeeeeees 15 Select Health studies at NIPH s sncean ae aacttes covecaewcatesind centececs ctondenwansueesccecedea eaten aa 16 Select source for human biological material at NIPH cccccceeseeeeeeeeeeeeeeeeeeeeeueeuaueanauags 16 Describe data sources outside Of NIPH ccccccce cece cece cece eee n nnn EEE EEE EES 17 Describe the data set from a selected Mandatory national health registry ccccecee eee e eens 18 EE 18 Describe the data set from a selected health Study aaauuuuana anna cece cece ee eee seen eeeeeeeeeeeeeeeneeenes 19 Describe the human biological material 00ccccseeeeeeeneeeesceecceeeeeeeeeeeeeessececceeeeeeetneees 19 Describe the variables ranannnnnnnnnnennnnnrvnnnnnnsnnnnnenennnnrnnnnunsnnnnnnennnnnnvnnnnnnnnnnnnennunnnnnnnne 20 Describe the Cala linkage aadnk evakpadndee 21 Fot Le teen ace Ra aN nae 21 Project description page 2 savanner dead ard de dende 22 POON DM TE NE EN EE E EE 23 Additional requirements aaauuv vr terete EERE EERE EERE EEE E TEETER EE EE EE EEE EEE REESE SEER SEES EEE E REESE ES 24 amet 25 CNN ONS rae Acetate eee ga ntae E T sin aaecen adeocnectwaniiera eecces sn aastanaenescemmense 26 User manual for electronic application for access to data Page 1 of 29 Attachments nd additional information saved ive 27 SUDMUILESCGE ADDNCALION AA ANG 29 Use
13. FHI manager and data and biological samples from health surveys FHI manages It is possible to search the data from several of these sources simultaneously as well as the linking of data from multiple sources Note that if you apply for a link with sources outside FHI eg Cancer Registry NAV SSB etc must also submit an application to these sources In the forms the word project appears in several contexts In the field of project title task we ask the name of the application The project manager is the person responsible for the use of data applied for For application to statistics there is no requirement to project beyond that he must keep and use the data in a proper manner Applications for research data representing the project manager responsible institution and must have research expertise By the time you start an application it is expected that you know what data you can apply for We ask for detailed descriptions of the sample and variables that apply for access It is not possible to select variables directly in the application form For some sources it is possible to attach variable lists from retrieved from other pages on fhi no For these sources there is an upload link on the page where you are asked to describe the dataset you are applying for and in the associated information text there is a link to external pages where the variable descriptions are available Once you have chosen and clicked on an application opens it in a se
14. HUSK The Hordaland Health Study O You are applying for data from HUSK The Hordaland Health Study Describe the data set 43 Save and Close Figure 22 Describe the data set from a selected health study AAA Describe how and from what data source the population base should be formed Alternatively state the number of individuals that are required to answer the research question s Which variables if needed and possibly which time period if the individuals have participated several times in the same study For more information about HUSK The Hordaland Health Study please click here Describe how and from what data source the population base should be formed Alternatively state the number of individuals that are required to answer the research question s Describe which variables if needed and possibly which time period if the individuals have participated several times in the same study There are always links to more information about the selected health study from the information texts Describe the human biological material folkehelseinstituttet Application for access to data Main sources Data sources Data set Medical Birth Registry of Norway MBRN HUSK The Hordaland Health Study Norwegian Mother and Child Cohort Study Describe bio material from MoBa Describe the variables Describe the data linkage Project Attachments Submit application Describe
15. They provide the input which is modified by the model to change the output Other independent variables are secondary factors that can affect the results of a study A covariate may be of direct interest or a confounder Note this page is only accessible when at least one health study is selected User manual for electronic application for access to data Page 20 of 29 Describe the data linkage folkehelseinstituttet Application for access to data AAA Main sources Describe the data linkage O Data sources You have stated that the project requires data files from Data set e Medical Birth Registry of Norway MBRN Medical Birth Registry of HUSK The Hordaland Health Study Norway MBRN Norwegian Mother and Child Cohort Study HUSK The Hordaland Health Study Describe how data is linked i e the data source register or health study the study population is drawn from and which other data sources that should be Norwegian Mother and Child linked to the study population Cohort Study Describe bio material from MoBa Describe the variables e Describe the data linkage Project Submit application Save and Close Figure 25 Describe the data linkage The 11 digit Norwegian personal identity number makes is possible to compile data from health studies registries and other data sources Describe the linkage i e which registry or health study which draws the sample and the other data sources
16. User manual for electronic applications for access to data at NIPH Table of Content Electronic applications for access to data at NIPH ccccccceeesseeeeeeeeeeeeeeeeeeesseeeeeeeeeeeetsseggggeennngs 3 POC 0 ERE eb enecudane seni aux E EE 4 KEENE ENE ES FEET EE RE NE amet 4 LOGEN on TINSE UNE added 5 Register a new application aaaaaaaa aa a annan anna nn nn nar nn nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 5 UNNE 6 PSN 7 NE PNL 8 aja ke es 9 19 1 sacacaasiasatenaaarsscasiamtanna E meanees esenens E E 8 About the application formS rrvvvrrrrrnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnne 9 Apply for tabular data statistics eiccvatn cove ct up dete cteaaenieneraeneuiaeeesebsteie dias penleentamemmiaeetesniieies 10 DB ClCCE Gala OCO EE OE E R EE 10 DEE NNN 10 eg ee EG EE EE NE EE SE 10 Project desScripti N adasirssaccsanss ctevinsensrvnnss sje sea saslepeka dienindessaansa bushes E a a ater ind 11 Principal investigator and billing address sssssssssnnusennnnennnnnnnnnnnnnnannnnsnuunnannnnnnnunsnnnnano 11 Attachments and additional information xaaannnvvrrrrrernnnnnnnnnnnnnnnnnnrennnnnnnnnnnnnnnnnnnennnnnnenn 12 K L 0 5 EE EEE anes 13 SUT TE GDDIICALION see 13 Apply for research data data and human biological material rrvvrvnnnnnnnnnnnnnnnnnnnnnnnnnnner 15 ENN ronin ue evenauecerrettaterna tue staa ceccauenneeneeneteatarie ates nena
17. bio material from MoBa O You have stated that the project requires biological material data from Norwegian Mother and Child Cohort Study Select the material by checking the boxes for the each source of material mother father child then select the type of material For each material please state the desired amount and the planned analysis Please describe objectives and methods Please describe the analysis the scheduled lab and the selection criteria for samples Mother Father Child Other Add analysis Add analysis Save and Close Figure 23 Describe the human biological material User manual for electronic application for access to data AAA The type and amount of biological material as well as the planned analysis on the material are important information that NIPH needs in order to assess the application If this is approved NIPH will ask for further details of the requested biological material For further information about the Norwegian Mother and Child Cohort Study MoBa lookhere Page 19 of 29 The type and amount of biological material as well as the planned analysis on the material are important information that NIPH needs in order to assess the application If this is approved NIPH will ask for further details about the requested biological material Describe the variables folkehelseinstituttet Application for access to data AAA Main sources Describe the variables O Da
18. ble to attach a variable list The lists must be prepared by the applicant in advance Where variable lists are available there is a Add variable User manual for electronic application for access to data Page 10 of 29 list function on the Describe data set page In the information text linked to the Add variable list heading there are links to current webpages with more information on how to create a list for the selected register The possibility to upload variable lists is only accessible where the registry has available assets to create lists Excel sheets PDF etc It is not mandatory to upload a variable list but where available it would be helpful for both the applicant and the caseworker Project description folkehelseinstituttet Application for statistical data AAA Data source Project Descri ption i Please describe in a short and concise manner why you need tabular data from Data set NIPH The project title will i Project Title Task be used as the name of the Project application both on the application side in the NIPH e Project Description 4 archive and in the communication with NIPH e Principal investigator and Specific objectives max 1500 characters A Billing Address Attachments Submit application Save and Close Figure 8 Project description On this page describe in a short and concise manner why you need tabular data from NIPH The project title will be used as the name of the app
19. c application for access to data Page 21 of 29 There are three project types Doctoral PhD PostDoc or Other If Other is selected please add a short description If the project is both PhD and PostDoc please select the most appropriate or select Other and describe The purpose and project description of the project must be academically sound and will be assessed according to the regulations that govern NIPH data sources i e that the research questions are within the purpose of the data source and other permissions applied for If several researchers are interested in the same research questions and apply for similar data NIPH will encourage them to cooperate either by working together on analysis and publication or by a division of the problem area List the research questions in a short concise manner preferably as questions in a bullet list Enter working titles for planned papers with a brief description of each publication the main exposure and the outcome If the publication schedule changes during the project NIPH should be notified NIPH strongly recommends using MESH keywords Find MESH keyword search here www nim nih gov mesh MBrowser html Project description page 2 folkehelseinstituttet Application for access to data AAA Main sources i ipti Oo gt In addition to the attached Project description page 2 research protocol NIPH ds project information f Data sources proc g the applicatio Summary max
20. ccess to statistics Most of them are the same as shown on the pages of the online application form Select data source Application for statistical data AAA Data Source 2 iradeyi se national health registries at NIPH you want tabular data statistics from It is only Select the mandatory national health registry at NIPH the project needs data from possible to select data from one register in one application If you have other Submit application Medical Birth Registry of Norway MBRN needs for tabular data please contact us Project Attachments a Cause of Death Registry Norwegian Cardiovascular Disease Registry HKR Norwegian Immunisation Registry SYSVAK Norwegian Prescription Database NorPD The Norwegian Surveillance System for Antibiotic Consumption and Healthcare Associated Infections NOIS Norwegian Surveillance System for Communicable Diseases MSIS Register of Pregnancy Termination Tuberculosis Register Next Page gt gt Save and Close Figure 6 Select data source Select the register you want tabular data statistics from It is only possible to apply statistics from the national health registers NIPH manages and only from one register at a time If you need linked data statistics from more than one register or from other NIPH sources use the form for access to data or contact NIPH at http www fhi no forskning and data datatilgang kontaktinformasjon After s
21. data The use of de identified data or person identifiable data in medical and health research requires prior approval by the Regional Committees for medical and health research ethics REC Use of anonymous data is not covered by the Health Research Act and should therefore not be considered by the REC Use of anonymous or de identified data from one or more mandatory national health registries does not require permission from the REC For more about REC please look at their webpages helseforskning etikkom no Applications that involves linkage with public records Socioeconomic data social security etc requires permission from the registry administrator Statistics Norway NAV Tax Authority The principal investigator that must obtain such permits before NIPH will grant access to data Statistics Norway has made available a list of frequently used datasets in research where the data can be ordered and which body that may grant an exemption from confidentiality For the Statistics Norway please look at their webpages www ssb no a microdata admreg html When applying for linkage of data the principal investigator must obtain permission from all records and or medical examinations that are part of the linkage eg Cancer Registry NPR Statistics Norway The NorPD regulations require a license from the Norwegian Data Protection Authority for linking NorPD data with other data sources than the mandatory national health registries
22. different application forms One covers statistics table data from the central health registers FHI manages With this form it is only possible to apply statistics from one register at a time If you want data from multiple tables use the form for application for access to research data Use Application for access to research data if you want data from the national health registers FHI manages health surveys and or human biological material from FHI User manual for electronic application for access to data Page 5 of 29 Stored applications Du er her Forside gt forskning og data gt datatilgang Norsk Feedback Stored applications Mre e a ieee feee keldckueucnd E a EAE EE ee Log out Stored applications era omme mwe MBRN statistics subset Application for reser 8 14 2014 8 14 2014 2 12 Principal Add co applicant statistical data 2 12 PM FM investigator Show PDF Impact study of several re for In progress ar 9 43 Principal Edit By co registers access to data investigator applicant Delete Application for In progress 8 19 2014 Principal Edit aa co access to data 10 54 AM investigator applicant Delete Changes in cause of Application for In progress 8 19 2014 Principal Edit a co Death in Norway access to data 10 39 AM investigator applicant Delete Register new application As you create applications or others add you as co applicant the list of stored applications will grow The list conta
23. dition to filling out this form Save and Close Figure 20 Describe collected data NIPH needs to know whether own collected research data biological materials clinical examination questionnaires etc either a ready collected research data or planned data collection will be linked to data sources from NIPH or if planned data collection will be linked or associated with one of NIPHs health studies Describe the data set from a selected Mandatory national health registry folkehelseinstituttet Application for access to data AAA Main sources Describe the data set Medical Birth Registry of Norway MBRN Describe how and from what data source the population base should be See peng seg You are applying for data from Medical Birth Registry of Norway MBRN the number of individuals e Medical Birth Registry of Describe the data set Please attach a file with variables below aa are ine ies to answer Norway MBRN the researc question s as well as which variables and period of time Data sources HUSK The Hordaland Health Study The Medical Birth Registry MBRN is a national health e Norwegian Mother and Child registry containing Cohort Study 4 information about all births in Norway The registry will help to clarify the causes Describe bio material from and consequences of health MoBa problems related to Upload Lists pregnancy and birth as well e Describe the variables o as to monitor the incidence
24. eep and use the data in a proper manner The name of principal investigator responsible institution and address are required before the application can be submitted If you are a private individual seeking access to statistics write your own name in the field of responsible institution If the billing address is different from the address above please check the box and fill in billing information If there is a need for multiple billing addresses enter these in the comments section of the page Attachments or add them as a separate attachment Attachments and additional information folkehelseinstituttet Application for statistical data AAA Data source Attachments and additional information O frie cannot exceed 20 MB per attachment NIPH accepts Data set attachments of the following Other attachments types plain text txt XML Project xhtml Microsoft Word doc Add file and docx Microsoft Excel and spreadsheets and PDF Sue spriten Zip files are not accepted Additional information Comments to the application sense agder te d If an attachment link is not visible on the page the upload has failed Then please check the size and format of the document If you have information that might be relevant for the application not stated elsewhere in this form please add this in the field for additional information For feedback on the application form please use the feedback link at the bottom of the page Save and C
25. electing registry the page to describe the required data sets is available Describe data set folkehelseinstituttet Application for statistical data AAA Data source Describe the data set Medical Birth H Describe how and from population base should be Project formed Alternatively state You are applying for data from Medical Birth Registry of Norway MBRN the number of individuals Describe the data set Please attach a file with variables below that are required to answer the research question s as well as which variables and Submit application period of time Attachments The Medical Birth Registry MBRN is a national health registry containing information about all births in Norway The registry will help to clarify the causes and consequences of health problems related to Upload Lists pregnancy and birth as well as to monitor the incidence Add file of congenital abnormalities Save and Close Figure 7 Describe data set Describe how and from what data source population base is formed selected with the number of individuals that are necessary to answer the research question s as well as the variable that are necessary and which time period The more precise description of the desired data set is the faster it is possible to process and make available the required data Remember to describe the period variable and population Variable lists For some of the central health registers it is possi
26. es you enter here Email First Name Last Name Academic degree Position Place of work organization department Work address Post code City Country Phone Cell phone Cancel Save If you are project manager on most applications or have a lot of information in common with the person or persons to be listed as project manager on the applications you can add information to this page The texts here will appear on the Project and billing address when you start a new application The texts can be edited in the application but changes will not be saved on this page Changes on these pages will not affect applications that are created User manual for electronic application for access to data Page 7 of 29 Change password iroa e lala orae Mere ala de 8 8 aa Mealea eee Change Password Change Password Current password New password Confirm new password il Cancel Save It is possible to change the password after login seven characters Add co applicants Application details Application type Principal investigator bes Created 8 14 16 PM Last updated 8 14 2014 3 03 PM Co applicants Norsk Feedback Log out Note that the new password must be at least Norsk Feedback Log out E mail Action Delete Add new co applicant E mail
27. for electronic application for access to data Page 16 of 29 If the project applies for data from other health studies or collects their own material please inform about this on the page Data sources outside NIPH Note that NIPH only handles requests for access to data from the registries health studies they manage Describe data sources outside of NIPH Application for access to data Main sources Data sources outside NIPH O Data sources Does the project apply for data from other mandatory national health registries e Mandatory national health Select from the list registries The Cancer Registry e Health studies The IPLOS Registry Norwegian Armed Forces Health Registry e Human biological material The Norwegian Patient Registry NPR e Data sources outside NIPH The Norwegian Surveillance System for Antimicrobial Drug Resistance NORM Project Attachments Select in the list Oo Submit application National Population Register Control and disbursement of health reimbursement KUHR Sources from Statistics Norway Medical quality registers Other health studies f ex HUNT Troms Medical records Other Has the project collected its own data or are there plans for collecting data e No O Yes Save and Close Figure 19 Describe data sources outside of NIPH In order to assess the application NIPH needs
28. ication You can apply for data from the health studies and registries where the Norwegian Institute of Public Health has the administrative responsibility Researchers can also apply for access to biological material from the biobank Before data or biological material can be released a full application must be submitted The project must be approved prices agreed and in some cases a contract must be signed with the Norwegian Institute of Public Health Please complete the appropriate application form depending on which type of data you need In addition NIPH requires a project description protocol and copies of any relevant licences Additional information can be forwarded to us after the application is sent in Applications are processed more quickly if all necessary paperwork is supplied Application for statistical data Researchers who are applying for statistical data do not need licences To apply for statistical data in the form of ready made tables use this application form Application for statistical data Application for access to data Researchers are responsible for acquiring all necessary licences This could be a licence from the Norwegian Data Inspectorate exemption from confidentiality from the Norwegian Directorate of Health or approval from the Regional Committee for Medical Research Ethics REC To apply for access to research data please begin the application form here Application for access to data There are two
29. ication in a few days You will receive an e mail with information from the case officer and further procedures when processing starts The time limit for delivery of material only begins when the application is approved More information about procedures and deadlines can be found at www fhi no artikler id 69867 If you wish to contact us use the information on the following page www fhi no artikler id 104529 Sincerely Norwegian Institute of Public Health PO Box 4404 N 0403 Oslo Switchboard 47 21 07 70 00 www fhi no Figure 14 Confirmation on email User manual for electronic application for access to data Page 14 of 29 Apply for research data data and human biological material Select main source s Application for access to data AAA sources of material health studies or registries at NIPH On the following pages you Data sources What kind of material from NIPH are you applying for select which registry or Project TEIA z health study you need Select by checking in the list below Note that the following pages will change terial fi If th ject depending on your selection ne pa der cor Attachments applies for biological material Data from NIPH s mandatory national health registries and data from the same Submit application health study select only Data from NIPH s health studies biological material from that health study In order to process the application quickly please
30. in Norway User manual for electronic application for access to data Page 25 of 29 Billing Information The billing address is different from the address above Address Post code City Country Billing Reference Save and Close Figure 31 Billing information Tick for separate billing information and fill in the form If there is a need for several billing addresses please add the information in the field for Additional information on the Attachments page or attach a document with the relevant information Co workers folkehelseinstituttet Application for access to data AAA Main sources Co workers Oo Please list all co workers that will have access to the data or material from NIPH Other project members may be listed Add co worker Data set Click on the Add co worker button to open the dialogue for registration Project Description f lt lt Previous Page Next Page gt gt e Project Description 2 e Approvals Save and Close e Additional Requirements Principal investigator and Billing Address Co workers Attachments Submit application Figure 32 Co workers Please list all co workers that will have access to the data or material from NIPH Other project members may be listed Click on the Add co worker button to open the dialogue for registration User manual for electronic application for access to data Page 26 of 29 Name E mail Acade
31. ins the following columns e Project title Displays the title placed in the application In addition to appear here the title is used in the NIPH public archives and project records e Type indicates whether it is an application for access to statistical data or application for access to research data e Status indicates whether the application is in progress or submitted e Last modified shows when it was last made changes to the application e My role shows whether you are applicant i e has started the application or is added as co applicant e Actions possible actions depends on the status of the application For applications in progress the following options are available o Edit opens the application for editing o Add co applicant see details below o Delete deletes the application after a warning For submitted applications the option Add co applicant is available and the option o View PDF opens PDF version of the application User manual for electronic application for access to data Page 6 of 29 Applicant information Norsk Feedback Stored applications f Register new application Applicant information Change Password Log out Enter default personal information for applications The information you enter here will appear on the page Principal investigator when you create a new application The information can be edited in each application Changes to the fields in an application will not affect the valu
32. lect the health studies at NIPH the project needs biological material and data For each health study you from will be asked to describe the Health studies CONOR Cohort of Norway ee sg on the gt Select which health studies the project needs data from by checking for the appropriate study in the list HUBRO The Oslo Health Study Human biological material For more information about which biological material NIPH manages click here HUSK The Hordaland Health Study Data sources outside NIPH Norwegian Mother and Child Cohort Study Norwegian Twin Registry NTR If the project applies for data Project i OPPHED Health Study Oppland and Hedmark from other health studies or Attach t collects their own material ae The Oslo Immigrant Health Study 2002 please inform about this later s ee The Oslo Study II in the application NIPH only Submit application y handles requests for the Roms s in Motion Study MoRo health studies in the list TROFINN Health Study Troms and Finnmark Save and Close Figure 18 Select source for human biological material at NIPH Select which health studies the project needs data from by checking for the appropriate study in the list For each health study you will be asked to describe the required data se on the following pages For more information about which biological material NIPH manages click here User manual
33. lication both on the application side in the NIPH archive and in the communication with NIPH The project title should be short and descriptive The title will appear in the project list on your NIPHs application page and in the equivalent list for co authors The title will also be used as a name in the NIPH public archive and project record Please make a sure you have a concise description of what the statistics will be used for NIPH will assess the application with regards to the legal purpose of each central health register Principal investigator and billing address folkehelseinstituttet Application for statistical data AAA Data source Principal investigator and Billing Address O Data set Principal investigat Name e Project Description e Principal investigator and E mail Billing Address bernette gmail com Attachments Academic degree Submit application Position Responsible institution Place of work institution department Address of work Post code City User manual for electronic application for access to data Page 11 of 29 Country Phone Cell phone Billing Information Q The billing address is different from the address above Billing Reference Save and Close Figure 9 Billing address The principal investigator is the person responsible for the application and data from FHI is granted access For application to statistics there is no requirement to project beyond that he must k
34. lose Figure 10 Attachments and additional information Note that attachments cannot exceed 20 MB per attachment NIPH accepts attachments of the following types plain text txt XML xhtml Microsoft Word doc and docx Microsoft Excel Open Office format for text and spreadsheets and PDF Zip files are not accepted Attachments appear as a link when they are loaded If an attachment link is not visible on the page the upload has failed Then please check the size and format of the document If you have information that might be relevant for the application not stated elsewhere in this form please add this in the field for additional information For feedback on the application form please use the feedback link at the bottom of the page User manual for electronic application for access to data Page 12 of 29 Validation folkehelseinstituttet Application for statistical data AAA Dat i i i i This page displays errors ata source Validation of your application O pene i mine corrected in order to submit Data set the application All errors Show PDF and deficiencies must be Project corrected before submission Click on the Attachments field name to open the page These fields must be corrected before the application can be submitted for corrections Submit application Click the field name to open the page for corrections Describe the data set Medical Birth Registry of Norway MBRN Describe the data set Input is
35. mic degree Position Institution department Phone Cell phone Should the co worker have accesss to the data Should the co worker be a contact person O m Figure 33 Add co worker Note that only name and email are mandatory fields Application for access to data Main sources Data sources e Project description 1 e Project description 2 e Approvals e Principal investigator and billing address e Co workers Attachments Submit application aAA Co workers e Please list all co workers that will have access to the data or material from NIPH Other project members may be Add co worker listed Click on the Add co worker button to open the dialogue Co workers for registration Name Actions James Bond Edit Delete Next Page gt gt lt Previous Page A A A Save and Close Figure 34 List of co workers The list of added co workers has functions for editing and deleting each person Attachments and additional information folkehelseinstituttet Application for access to data Main sources Data sources Data set Project Attachments Submit application Attachments and additional information O op Dr rn protocol and the PIs CV must be attached Note that attachments cannot exceed 20 MB per attachment FHI accepts attachments of the Add file following types plain text txt XML xhtml Microsoft W
36. missing Project Description Project title Input is missing Specific objectives Input is missing Principal investigator and Billing Address Name The field must have a value Responsible instiution The field must have a value Work address The field must have a value Post code The field must have a value City The field must have a value Figure 11 Validation This page displays errors and omissions to be corrected before it is possible to submit the application All errors and deficiencies must be corrected before submission Click on the field name to open the page for corrections To view the full application in context click on the PDF view PDF contains a table of all the field names with associated information folkehelseinstituttet Application for statistical data aAA This page lists the fields ee Summary 8 that are required to be filled in before the application can Dataset be submitted Click the field The application is ready to be sent name to open the page Project where the correction should Show PDF be performed To see the Attachments full application in context please click on the PDF icon Submit application The PDF displays all the field names with associated information Save and Close Submit Application Figure 12 Submit application Submitted application folkehelseinstituttet Thank you Your application has been submitted You will soon receive a confirmation e
37. o change It could imply that new information is required or that added information is deleted with no further warning Navigation area Input area Information area elkehilsehstnuttet Buttons At the bottom of the input area there are buttons for navigating to next or previous page and to close the form Information is saved when the applicant navigates to another page either by clicking on the next or previous buttons or by using the navigation bar to the left and when she selects Save and close If the applicant closes the form by clicking on the x in the right corner of the screen recent changes to the open page is not saved Some browsers will detects unsaved changes and ask the applicant if she wants to save but the Save and close button is a safer choice To change the text size hold down the Ctrl button and press for larger text and for smaller text If you need help to fill out the form or if you experience technical difficulties with the form contact datatilgang fhi no We welcome your feedback on the design of the form and have therefore added an option for feedback at the bottom of the screen Below you will find information texts to all fields in the application form for access to tabular data and to research data User manual for electronic application for access to data Page 9 of 29 Apply for tabular data statistics Below you will find information texts to all fields in the application form for a
38. ord doc and docx Microsoft Excel open office format for text and Principal investigator s CV with list of publications for the last five years peike ai Research Protocol Add file Attachments appear as a link when they are loaded If an attachment link is not visible on the page the upload has failed Then Other attachments please check the size and format of the document Add file If you have information that might be relevant for the application not stated elsewhere in this form Additional information k lease add this in the field or additional information For feedback on the application form please use the feedback link at the bottom of the page Save and Close Figure 35 Attachments and additional information User manual for electronic application for access to data Page 27 of 29 A project description protocol and the PIs CV must be attached Note that attachments cannot exceed 20 MB per attachment FHI accepts attachments of the following types plain text txt XML xhtml Microsoft Word doc and docx Microsoft Excel open office format for text and spreadsheets and PDF Zip files are not accepted Attachments appear as a link when they are loaded If an attachment link is not visible on the page the upload has failed Then please check the size and format of the document If you have information that might be relevant for the application not stated elsewhere in this form please add this in
39. parate window That way you can switch between screens to find information sources without having to open the application again When a new application is started it is also available in the list of saved applications Electronic application for access to data is tested ok in newer versions of Internet Explorer 9 and above Firefox Opera and Safari The solution can be used but are not optimal in IE 7 and 8 The solution is not adapted for use on a tablet or mobile User manual for electronic application for access to data Page 3 of 29 Logon Norsk Feedback Email Password Remember me on this computer Register new user Forgot your password Figure 1 Logon Applicants must register as a new user before logon There is a link to register new user on the login page Register new user Email login name Password Retype password Figure 2 Register new user To register the user must enter an email address as user logon name and a password of your choice Norsk Feedback e The password must be minimum 7 characters long Email login name The password must be Password minimum 7 characters long Retype password Figure 3 Length of password The user must enter the password twice to ensure that the word is spelled correctly The password must be at least seven characters Once the user has registered a confi
40. ponsible institution oe Co workers Attachments z Place of work institution department Submit application Address of work Post code City Country Phone Cell phone Billing Information Oo C The billing address Is different from the address above Billing Reference Save and Close Figure 30 Principal investigator aAA gt The principal investigator is responsible for the daily operations of the research project and should hold necessary research skills If needed please add a separate billing address below For applications for access to biological material it is possible to state several billing addresses in a second form that is submitted after the project has been granted access to the material The principal investigator is responsible for the daily operations of the research project and should hold necessary research skills If needed please add a separate billing address at the end of the page For applications for access to biological material it is possible to state several billing addresses in a second form that is submitted after the project has been granted access to the material The principal investigator is responsible for the daily operations of the research project and should hold necessary research skills For multicentre studies the Regional Committees for Medical and Health Research Ethics REC requires that the project has at least one principal investigator
41. r manual for electronic application for access to data Page 2 of 29 Electronic applications for access to data at NIPH The electronic application for access to data is the system applicants has to use in order to apply for data from mandatory national health registries and health studies the Norwegian Institute of Public Health manages It should also be used for applications for access to human biological material from NIPH The electronic forms replace the paper schemas S601E S601BE and S602E To make an application you must first log on application pages The reason is that the solution keeps track of all the applications you work with as well as those submitted If this is the first time you use the online application form at FHI must register as a new user Once you are logged in choose whether to edit an application in progress from the list of stored applications or start a new application from page Register new application There are two types of forms Application for access to statistical data table data or Application for access to research data In the application for access to statistical data table data is only possible to apply statistics from one of the key health records at a time If you apply statistics from several registries you either have to submit multiple applications or use the form for research data In the application for access to research data it is possible to search for data from the national health registers
42. rmation If the project applies for data from other health studies or collects their own material please inform about this later in the application NIPH only handles requests for access to data from the health studies in the list The Oslo Immigrant Health Study 2002 The Oslo Study I The Oslo Study II Pneumokoniosis Study in Hordaland 1988 1990 Roms s in Motion Study MoRo TROFINN Health Study Troms and Finnmark X ray screenings 1943 1999 Youth Studies 2000 2009 Save and Close Figure 17 Select Health studies at NIPH Select which Health studies at NIPH the project needs data from by checking for the appropriate study in the list For each health study you will be asked to describe the required data se on the following pages NIPH administers a variety of health studies For more information about the Health studies at NIPH please look at the webpages www fhi no If the project applies for data from other health studies or collects their own material please inform about this on the page Data sources outside NIPH Please note that NIPH only handles requests for access to data from the registries health studies they manage Select source for human biological material at NIPH Application for access to data AAA Main sources Human biological material and data from health studies at NIPH O Mandatory national health 4 i 5 registries Se
43. rmation mail is sent to the email address specified as user logon name Norsk Confirm email Feedback A link has been sent to gmail com Please click the link and follow the instructions on the page If you need a new link click here Send a new link Cancel Figure 4 Confirming email has been sent User manual for electronic application for access to data Page 4 of 29 Confirm email Feedback A link has been sent to fs i edda gmail com Please click the link and follow the instructions on the page If you need a new link click her end a new link Cancel Figure 5 Confirmation email Click link to create user The new user must click the link in the confirmation email before she can log onto the application site On the login page it is possible to request a new password It is possible to change the password after login Logged on first time Norsk Feedback Stored applications Erie e ete tol ad Mealea ae al Mee ale deal Log out Stored applications No stored applications Register new application The first time you log in the list of stored applications is most likely empty The exception is if you are added as co applicant on other applications To start a new application click on the Register a new application tab or button Register a new application Norsk Feedback Sinela te ls s le lelegicm Register new application fjes aa ere de te eg Log out Select appl
44. rwegian Immunisation Registry SYSVAK NIPH is responsible for 10 of e Data sources outside NIPH i _ the 15 mandatory national Norwegian Prescription Database NorPD health registries Each Project The Norwegian Surveillance System for Antibiotic Consumption and mandatory national health Healthcare Associated Infections NOIS registry is governed by Attachments separate regulations Read Norwegian Surveillance System for Communicable Diseases MSIS more about the NIPH Register of Pregnancy Termination mandatory national health registries here Submit application Tuberculosis Register If the project applies for data from other mandatory national health registries or collect their own material please inform about this later in the application NIPH only handles requests for access to data from the registries in Save and Close the list Figure 16 Select Mandatory national health registries at NIPH Select which Mandatory national health registries at NIPH the project needs data from by ticking for the appropriate registry in the list For each selected registry you will be asked to describe the required data se on the following pages NIPH is responsible for 10 of the 15 Mandatory national health registries Each Mandatory national health registry is governed by separate regulations For more information about the Mandatory national health registries at NIPH please look at the webpages www fhi no
45. s work related to giving access to data or biological materials For more information see here www fhi no research and data data access prices Approvals folkehelseinstituttet Application for access to data AAA Main sources Oo Use of anonymous data is Approval not covered by the Health Research Act and should Data sources therefore not be considered Does the project require an approval from the Regional Committees for Medical by the Regional Committees Data set and Health Research Ethics REC for medical and health Yes a copy of the application and approval from the Regional Committees for ethics REC Project d edge d use of de identified data or Medical and Health Research Ethics REC are attached personally identifiable data in e Project Description Yes copy of the application and approval from the Regional Committees for medical and health research Medical and Health Research Ethics REC will be forwarded requires prior approval by Project Description 2 No the project does not need an approval from the Regional Committees for Medical and Health Research Ethics REC The NorPD regulations Approvals requires a license from the Norwegian Data Protection e Additional Requirements Authority for linking NorPD data with other data sources Principal investigator and Billing than the central health Address Yes a copy of the exemption is attached registries In the absence of consent from the study pop
46. specify as accurate as possible the project s oss requirements More information about the material that NIPH offer is available at www fhi no Biological material and data from health studies at NIPH Save and Close Figure 15 Select source Select one or more main sources of material health studies or registries at NIPH On the following pages you select which registry or health study you need material from If the project applies for biological material and data from the same health study select only biological material from that health study In order to process the application quickly please specify as accurate as possible the project s requirements More information about the material that NIPH offers is available at www fhi no Select Mandatory national health registries at NIPH Application for access to data AAA Main sources Mandatory national health registries at pr NIPH Select which mandatory Data sources national health registries at NIPH the project needs data Mandatory national health from by ticking for the registries Which registries does the project need data from appropriate registry in the Cause of Death Registry list For each selected e Health studies registry you will be asked to Medical Birth Registry of Norway MBRN describe the required data se e Human biological material Norwegian Cardiovascular Disease Registry HKR on the following pages No
47. ta sources You have stated that the project requires data from Data set e Medical Birth Registry of Norway MBRN e Medical Birth Registry of HUSK The Hordaland Health Study Norway MBRN i e Norwegian Mother and Child Cohort Study e HUSK The Hordaland Health Study Describe how the given variables are to be used in the project e Norwegian Mother and Child Describe dependent variables outcome o Cohort Study e Describe bio material from MoBa e Describe the variables e Describe the data linkage Describe independent variables main exposure Oo Project Attachments Submit application Describe other independent variables confounders or covariates i Figure 24 Describe the variables Please provide precise descriptions of the dependent variable outcome and the main explanatory variables These shall be in accordance with the project objectives There is no exclusive right to the variables as such but an exclusive right to publish about a precise issue within a limited time This means that even if a researcher has been given a wide set of variables the rights to analyze and publish results from the dataset is limited to the given objectives main exposure and outcomes as described in this application The dependent variable outcome are variables where the value is assumed to be dependent on the effect of other variables exposures The independent variables are the values that can be changed in a given model or equation
48. the field for additional information For feedback on the application form please use the feedback link at the bottom of the page folkehelseinstituttet Application for access to data AAA Main sources Validation of your application O gt Tei page eye ees and omissions to be corrected in order to submit Data sources the application All errors Show PDF and deficiencies must be Data set corrected before submission Click on the Project field name to open the page These fields must be corrected before the application can be submitted for corrections Attachments Click the field name to open the page for corrections Describe the data set Medical Birth Registry of Norway MBRN Describe the data set Input is missing Describe the data set HUSK The Hordaland Health Study Describe the data set Input is missing Describe the variables Dependent variables Input is missing Independent variables Input is missing Other independent variables Input is missing Describe the data linkage Description of data linking The description is missing Attachments and additional information Attachment research protocol Missing attachments Principal investigator CV Missing attachments Save and Close This page displays errors and omissions to be corrected in order to submit the application All errors and deficiencies must be corrected before submission Click on the field name to open the page for corrections Application for
49. ulation will also require Does the project require exemption from the law of professional secrecy G Yes the exemption will be forwarded Co workers No exemption is required an exemption from professional secrecy from Attachments REC Submit application Applications that involves Are permissions required from data owners outside of NIPH Q linkage with public records Er r Socioeconomic data social Yes a copy of the permissions is attached security etc requires Yes a copy will be sent permission from the registry administrator Statistics Norway NAV Tax Authority The principal investigator that must obtain such permits before NIPH will Does the project require a license from the Norwegian Data Protection Authority grant access to data Statistics Norway has made available a list of frequently Yes a copy of the application and approval from the Norwegian Data used datasets in research Protection Authority are attached where the data can be ordered and which body that may grant an exemption from confidentiality Click No Yes a copy of the application and approval from the Norwegian Data Protection Authority will be forwarded No the project does not need an approval from the Norwegian Data here for the Statistics Protection Authority Norway list Figure 28 Approvals There are different requirements for approvals depending on the type of research data the degree of person identifiable data and linkage of
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