Online Forms User Manual
Contents
1. project to another user refer to section 8 Page 11 of 46 Steps 4 The six form level tabs relate just to the main form not to the project as a whole and will only be visible when the form type i e HDEC SCOTT or MDF is selected in the project tree at E the left of the screen n e The Navigate tab contains the form refer to section 6 e The Documents tab allows you to attach relevant documents to your form refer to section 7 e The Transfer tab is used to temporarily transfer the form to another user refer to section 8 e Inthe Authorisation tab you can request electronic signatures from the CI sponsor etc refer to section 10 HOME MY PROJECTS MY CONTACTS Screenshots Online Forms HELP CONTACT US Not named yet HDEC Navigate Documents Transter Authonsation e Submission Post approvai Click here to begin completing reviewing the form or click on the Navigate by question numbers SCREENING QUESTIONNAIRE RESEARCH AND STUDY TYPE MAIN CRITERIA e Inthe e submission tab you can check your application is complete prior to submission refer to section 9 submit for review refer to section 11 and monitor the progress of your submission refer to section 12 e The Post approval tab allows you to create Post approval forms to submit amendments progress reports etc refer to section 18 Page 12 of 46 6 Complete the form How to comple2. above You can remove a recipient by a CR SK pou A UE 7 Md clicking Remove Page 32 of 46 Can recipients of email notifications access the project in Online Forms Not necessarily For others to have read only access to the project in Online Forms you must request authorisation from them Do users who have authorised the main form automatically receive email notifications No Apart from the form owner only email addresses entered in the Email notifications tab will receive email notifications l ve not received email notifications but should have What has gone wrong Check your spam folder for emails from admin Q ethics health govt nz Page 33 of 46 Overview of Online Forms MDF and PAFs Create new project MDF for studies approved before 1 July 2012 i Complete Form i Request Authorisation if you are not the CI V Submit V Create and submit Post Approval Forms for amendments progress reports etc Page 34 of 46 17 Create and submit a Minimal Dataset Form for a study approved before 1 July 2012 If your study was approved before 1 July 2012 you need to register your study in the new system by creating a Minimal Dataset Form or MDF To submit post approval items amendments progress reports etc you must create a Post Approval Form you will be unable to do so unless you have first created and submitted an MDF You only need to submit an MDF once per st
3. is who have a restricted ability to make independent decisions about their participation standard treatment being withheld from one or more participants the storage preservation or use of human tissue without consent none Please briefly explain why you believe that one or more Participants who are vulnerable are participants in your study are vulnerable those who have restricted capability 200 words to make independent decisions about their participation in the study Examples of these include e children and young people e people with mental illness e people with serious intellectual disability people with English as a second language and or a different cultural background to the investigators for studies whose details are primarily or only stated in English people whose freedom to make independent choices is restricted e g prisoners employees of a sponsoring company or students people with serious illness for which the study treatment offers potential benefits that substantially exceed those of any other available treatment Page 46 of 46
4. 30 of 46 15 Duplicate or Delete a Project The Manage tab allows you to duplicate the information in an application into a new project or to delete an entire project Steps Screenshots 1 Open the project and click on the Manage tab A e roe Online Forms Note that this project level tab will only be visible when My Project is selected in the project tree at the left of the screen 2 To delete the project click Fan Delete Project Online Forms HOME MY PROJECTS MY CONTACTS HELP CONTACT US A pop up window will appear Click OK to delete the project permanently Once the project has been deleted you will not be able to retrieve it 3 To duplicate the project click Duplicate Project If the project includes post approval forms and you d like to duplicate these too make sure that the check box is ticked beforehand Otherwise leave it unchecked A pop up window will appear Click OK to duplicate the project A cw Leaien A Online Forms HOME MY PROJECTS MY CONTACTS HELP 4 Click on Existing Projects in the My Projects menu A duplicate project will appear in your list of projects Note that documents and authorisations associated with the original project are not 2 cmt duplicated and will need to be added in the normal way HELP CONTACT US Requests for Authonsation Transfer Requests tanage Weed ke Ta Projects Requests for Authonsation Transfer Requ
5. Disability Ethics Committees Don t hesitate to contact us if you d like help answenng these questions or any others in the HDEC form A Health and disability research To print a PDF copy of your form click Print Draft To mark a page as incomplete click Incomplete Will your study aim to improve health and independence outcomes Yes Page 1 of 88 NZ HDEC Form Page 13 of 46 Full vs Expedited Review The one HDEC form is used for all applications regardless of review type full expedited The answers you provide in the screening questions will determine whether the application will be reviewed via the full or expedited pathway Page 10 of the form states the review pathway your application will be assigned to An application assigned to the full review pathway is reviewed at an HDEC committee meeting The committee has 35 calendar days from the close of agenda to review the application and make a final decision This timeframe may be suspended once for up to 90 calendar days when the committee requires additional information in order to make a final decision An application assigned to the expedited review pathway is reviewed by a subcommittee comprised of the Chair and up to two other members This does not involve a physical meeting of the committee A final decision must be made within 15 calendar days This timeframe may be suspended once for up to 90 calendar days when additional information is required in
6. Requests for Authorisation Transfer Requests CONTACT US reate New Project Manage Project Categories Projects Requests for Authorisation 1 Transfer Requests Approved Projects U Old Projects 14 Manage Categories RECIPIENT OWNER There are no new requests for transfer Projects Requests for Authonsabon 1 HOME MY PROJECTS MY CONTACTS HELP Not named yet Form Type MDF Reference None Form Section N A Signatures None CJ My Project MOF Patnarch Gi Joe Patnarch Gi Joe CONTACT US 25 09 2012 15 22 04 07 2012 13 06 19 06 2012 14 56 25 09 2012 14 18 03 09 2012 12 12 Nawgate Documents Authonsation e Submission Mr Rohan Murphy Y Include personal message Page 19 of 46 9 Check for Completeness It is important to check for completeness before you request authorisations to make sure you have answered all the questions in the form Steps Screenshots 1 Open the project and click on the e Submission tab 4 line F Online Forms Note that this form level tab will only be visible when the form type HDEC SCOTT or MDF is selected in the project tree at the left of the screen 2 Click on Check for Completeness to identify missing information from your application Any outstanding items will be listed ication Once all mandatory questions documents and authonsations have been completed you may then procee
7. an authorisation TEE ts s t request by clicki ng the Recall Yos may ened ta chtsin aubodestione tam athar Ouine Fes ees bale cubre you applica orba begining you study at leat Te request authonsation smply click request and enter the authonser s username jwhich will aiso be ther email address The authoriser wil recene an emai alerting them to ths request and asiong them ts log in to Ondine Forms to n b u tto n Chck hers for detais cf usernames to use in requesting authonsation from amp stnct health boards and some other organisations A uthonsaton types wd ont be enabled once rei art Questions have been answered n the fom The fclicwing eiectromc authonsatons are scaiabie for thes form type Matus Segneng User Requested Ms Emma Phelan liat requested Not requested iot requested Electronic Authensatons History Date Action 20 09 2012 1342 PM Request for authonsabon sent by Ms Sarah Deigadc tc Ms Emma Pheian 6 You can also revoke an eee eee authorisation that has already You may need to obtam authonsations from other Onine Forms users before submttng you apphcaton or before beginning your study af a e e n g ra n e y C l C l n g e To request authonsabon simply check request and enter the authonser s usemame which wall also be thew email address The authonser wil recene an emal alerting them to this request and asiong them to log in to Onine Forms to Ml R k H b tt Cack here for deta s of usem
8. and Upload will be visible 2 Inthe Upload sub tab select AA Online Forms the document type you wish to ae eee cee upload from the drop down list Enter a version number date and description for the document The details you enter here will appear in the letters you receive from HDECs SCOTT Click browse to find the document on your local drive then click Upload File 3 This will take you back to the 45 niine Forms List sub tab which will now INCLINET display the document you have just uploaded Return to step 2 to upload another document Click View Manage to view or delete the document or to replace it with an updated version Page 15 of 46 Steps Screenshots A a Online Forms 4 Note that if you upload a new version of the same document the old version remains in the Online Forms system unless you delete it yourself HOME MN PROSECTS MN CONTACTS HELP s cT However only the most recent version will be submitted with your application Mandatory Documents Documents such as the protocol and CV for Co ordinating Investigator must be uploaded with every application while other documents become mandatory depending on the answers you give in the form Document type Protocol CV for Co ordinating Investigator Cl CVs for other Investigators Evidence of favourable peer review Investigator s Brochure Participant Information Sheet Consent Form
9. be ther email address The authonser wil recewe mai E nte r t h e e m a i a d d ress of th e Chick here for detais of usemames to use in requesting authonsation from dstnct health boards and some other organessbons Aujthonsabon types will only be enabled once relevant quesbons hawe de 1 M The following electron authonsabons are available for this form ty autnoriser and Inciuae a persona Erter e mai address d ha parson tom whem you wesh to Pnnt ax honsation report obtam an electrorsc authonsation and press Send Request An Madad request wll be sent to the user message if necessary Click the Coordi Send Request button m PA Please note that the authoriser must have an account with Online Forms 3 As the author of the form you will receive automated emails advising you of the progress of your authorisation request E 4 Electronic Authorisation Given Online Forms Ms Sarah Delgado Dear Ms Sarah Delgado If you need further help or assistance please e mail us at helpdesk infonetica net or phone 0800 63 Regards HDEC SCOTT Form https ethicsform org nz This is a system generated e mail Please do not reply 4 Once the authorisation is given a green tick will appear next to it An authorisation history at the bottom of the page keeps a record of all authorisation requests You can also print an authorisation report for your records Page 22 of 46 Steps Screenshots 5 You can recall
10. his or her medical Ld no history information about any disabilities that individual has or has had information about any health services or disability services that are being provided or have been provided to that individual information in connection with the donation by that individual of any body part or any bodily substance information derived from the testing or examination of any body part or any bodily substance of that individual information about the individual which is collected before or in the course of and incidental to the provision of any health service or disability service to that individual HDEC review is not usually required for studies that involve the Answer yes to this question if use or disclosure of health information where e You have informed consent e thisuse or disclosure has been authorised by the to use this health individual s concerned or information Page 43 of 46 e health information will not be disclosed to researchers in a form that could identify or could reasonably be expected to identify the individual s concerned or could allow for the information to be matched with other data sets for example through the use of non encrypted identifiers such as NHI numbers Does one or both of these exceptions apply to your study ves no Exemption for low risk medical devices Studies on low risk class I medical devices as defined from page 77 of the Austr
11. in the box below in order to transfer the form to an e mai address the recipient must have an account on the online form system Thus option is for transfemng a form to a collaborator Recipsent e mas include personal message Transfer To User No Transfers to amp splay hew les A ent Online Forms Test application None Form Secbor N A Signatures None My Praet ProjectFier Transfer Manage EmaiNot cstons Please enter the recipient s e mail address in the box below in order to transfer the form to an e mail address the recipient must have an account on the onkne form syste aw Post approval Forms Recipient s e mail include personal message gt gt Transfer To User lt lt No Transfers to display Project Fiter Transfer This form has been transferred to another user To retrieve the form from this user s account the user will no longer have access to the form click the Retrieve Project button Include personal message Retrieve Project To permanently transfer this form to another user chck the Permanently transfer this form button Include personal message gt gt Permanently transfer this form lt lt Transferred From 25 09 2012 03 19 PM 25 09 2012 03 18 PM Patriarch Gl Joe Patriarch Gi Joe Project Filter Transfer This form has been transferred to another user To retrieve the form from this user s account the user will no longer have a
12. order to make a final decision My application is out of scope If after answering the screening questions you are confident that your study does not require HDEC review then please approach the research office at your university or DHB to discuss your study and the internal ethical review process If you are unsure of why your study is out of the scope of HDEC review or if you require formal acknowledgment of this then you are welcome to continue completing the questions in the form by clicking Next and then submit your application Page 10 of 88 1234567 9 10 11 the Online Form to help you think through the ethical issues involved in your study You can 2 v ther parties to your study such as localities e g DHBs w processes Contact details for some institutional Ethics Page 10 of 88 NZ HDEC Form Page 14 of 46 7 Upload study documents How to upload study documents Online Forms allows you to attach study documents such as protocols investigator s brochures and participant information sheets to your application for HDEC or SCOTT review Mandatory documents must be uploaded before you can submit the form to the review body Steps Screenshots 1 Open the project and click on the nine Forms Documents tab Note that this form level tab will only be visible when the form type HDEC SCOTT or MDF is selected in the project tree at the left of the screen Two sub tabs List
13. that any changes made to the form will invalidate the authorisations that are in place but uploading extra documents will not invalidate these Mandatory authorisations Mandatory authorisations must be obtained before you can submit the form for HDEC review however you can request non mandatory authorisations e g locality authorisations at any time Authorisation type Mandatory prior to submission Co ordinating Investigator Cl Yes Other Investigator No Primary contact person Yes Sponsor Yes unless no sponsor at a 5 1 Third party performing sponsor s duties or functions in NZ Yes if yes at a 5 3 Localities No Other No Page 21 of 46 How to request authorisations Steps Screenshots 1 Open the project and click on the Authorisation tab Note that this form level tab will only be visible when the form type HDEC SCOTT or MDF is selected in the project tree at the left of the screen This tab will list all the electronic authorisations that are available for that particular form 2 S t t h t t f Naegate Documents Transfer Authonsation Submission Post approval elec e relevant type o Authorisations a ut h O r i se r a n d C IC k u Re u est You may need to obtain authorsatons fom other Online Forms users before submitting your application or before beginning your study at a locality q To request authonsabon simply chck request and enter the authonser s usemame which vall also
14. ti m e by C C ki n g O n This form has been transferred t ETE To retneve the form from this user s account the user will no longer have access to the form click the Retneve Form button include personal message D the Retrieve Form button The transfer actions are listed in I Pana Gas mma the transfer history 24 09 2012 10 46 AM Page 17 of 46 Transfer a project permanently You can transfer a project permanently if you would like to give somebody else full and permanent control of the project Steps 1 Open the project and click on the Transfer tab Note that this project level tab will only be visible when My Project is selected in the project tree at left of the screen Please note that this transfer tab is different to the one shown in the previous page 2 Enter the recipient s email and click Transfer to User Automated emails are generated advising the recipient and owner of the actions taken at various stages of the transfer Please note that the recipient of a transferred form must have an account with Online Forms first 3 Once the recipient has accepted the form click on Permanently transfer this form 4 Click OK Please note that this will permanently transfer the project and you will not be able to retrieve it Once transferred the project will disappear from your existing projects Screenshots Faia Online Forms et the recipients e mail address
15. 00 00 Page 28 of 46 13 Recall an application submitted for HDEC review Please note the recall option is only enabled if the application is pending registration by the review body i e the submission is awaiting the committee secretariat to upload the application If your application has been successfully recalled you may amend the form upload amend your supporting documents and request authorisations prior to re submitting the application If you are not able to recall your application and would like to withdraw your application at any time please contact the secretariat at hdecs moh govt nz or on 0800 4 ETHICS Steps im Open the project and click on the e Submission tab Note that this form level tab will only be visible when the form type HDEC SCOTT or MDF is selected in the project tree at the left of the screen Once in the e submission tab click the Recall Submission button at the bottom of the page Screenshots Online Forms x HOME MYPROJECTS MYCONTACTS HELP CONTACT US Page 29 of 46 14 Submit a response for a provisionally approved study If your study has been provisionally approved please send your response to hdecs moh govt nz as we currently cannot receive responses via Online Forms Once your study has been fully approved this will be reflected in the status of your project in Online Forms and you will be able to submit Post Approval Items see section 18 Page
16. 12 As soon as the MDF is submitted you can submit post approval items such as annual progress reports and amendments Page 36 of 46 18 Create and submit a Post Approval Form What is a Post Approval Item A post approval item is an item submitted for HDEC review after a study has been approved Examples of post approval items include substantial amendments annual progress reports protocol deviations or violations notifications of conclusion of study final reports Substantial vs Minor Amendments As per the HDEC Standard Operating Procedures an amendment to an approved study only requires HDEC review if it is substantial Applicants may make minor amendments to an approved study at any time without approval from or notification to the HDEC SUBSTANTIAL AMENDMENTS Significant amendments are required to be submitted for HDEC review Examples of these include Significant changes to the design methodology of the study Significant changes to the type and or number of procedures undertaken by participants Changes relating to the safety of physical or mental integrity of participants or to the risk benefit assessment for the study Significant changes to study documentation such as participant information sheets The appointment of a new CI Any significant change to the study protocol or the information provided in the application for approval Notification of urgent safety measures taken to p
17. Disability Ethics Committees Online Forms User Manual 0800 4 ETHICS 0800 634 758 or 64 4 974 7675 hdecs 29moh govt nz Version 1 0 October 2012 Page 1 of 46 I would like to 1 Greater account I ONIME FONS s wesc ees erecta ees trots E 4 2 Log in to my Online Forms account and manage my account details 5 3 Create Edit or Delete Contacts esses eene hene nhe hhe hee rhen iren sse trenes sens ena 6 4 Manag ero ech C dlegOrIBS s cdeeerutu isses tent nU Es EI UIURURSINEII I PII SES DSEP ID DIM E EISE S DP DRE 10 5 i i 0 2 0 0 0 NR IR NR DIU NIE NE DS RI ECP DN NR OR NR RR TE NR E 11 6 Compe ETOO ecd cu uU UL AM AME ELM uu EE 13 7 Upload Stay JOCUMEM S aste ERE M a aS 15 8 Transter atomo OUNCE ESO sere e na E O EOE 17 9 CNRECKTOF COMPIE ONES sate a ee EE E E LIII 20 O Ja80H8S OP aan t VABUTIOEHSQUOES ore EE 21 MEME O cgo ae RD 26 12 Follow the progress of my submission and view correspondence from HDECS SCOTT 28 13 Recall an application submitted for HDEC review sess 29 14 Submit a response for a provisionally approved study sess 30 I5 Duplicate or Delele d T TOIGOL merpeneerecrrecr racers treserertrerter rv rert ts rerert rs rece rtrs ers rere rere rere rer rerere etre 31 TO OCl UD Cliall NOUNCAUONS Tor DFOIBOL s secte usee Eee SEE DE SEINS A OOO ERE E EDE TERETE 32 17 Create and submit a Minimal D
18. E MYPROKCIS MYCONTACTS HELP CONTACTUS e g progress report then Test MDF answer the remaining questions Form Type Postapprovsi in the form m sene va Please note that all 7 pages 29 T won t be active only those ET relevant to the post approval D we mszms item you have chosen an amendment Oa progress report O a protocol deviation or violation O a report of a serious adverse event to SCOTT only Once you have completed all notlication cf conclusion ofthe stud questions click the Navigate icon to go back to the form tabs as shown above Oa final report Page 1 of 7 7 Upload any documents associated with your post approval item in the Documents tab For instructions on how to upload documents please refer to section 7 8 Inthe e Submission tab click gt Online Forms Check For Completeness If your form is complete you can submit it by clicking Proceed to Submission History and then click Submit You will receive an automatic email once your PAF has been registered in the system You can view correspondence form the HDEC in the PAF s e submission tab by clicking on the icon in the submission history see section 12 recall a submitted apphcation f the appkcation is either per You may on e Page 39 of 46 Health and j b Disability pu g Committees 19 Adda new locality Before a study commences at a gi
19. Not named yet Not named yet Not named yet Not named yet s MDFs Edit i Page 10 of 46 5 Create a new project A project consists of e one main form which can be an HDEC form a SCOTT form or a Minimal Dataset Form and e any number of post approval forms Steps Screenshots 1 Goto My Projects in the main menu and select Create New E Project TUM ees Create New Project a Mr Rohan Murphy ecart ze M y Accourt Logout Online Forms Requests for Authorisation Transfer Requests Or if you are already in the My D aa Projects screen simply click the Create New Project button 2 Anew project titled Not named ON Online Forms yet will appear T 3 A project has two levels of tabs the project level tabs and the form level tabs The four project level tabs allow zu IX you to control the project as a pti eii whole and will only be visible when My Project is selected in the project tree at the left of the a Minimal Dataset Form MDF for a study that was originally submitted to an HDEC or SCOTT prior to 1 July screen e The Project Filter e Inthe Manage tab you can duplicate or delete determines the type of form a project refer to section 15 HDEC SCOTT or MDF e In Email Notifications you can nominate who e The Transfer tab is used to you wish to be included in email notifications permanently s from HDECs or SCOTT refer to section 16
20. PIS CF PIS CF for persons interested in welfare of non consenting participants Surveys questionnaires Evidence of sponsor insurance Evidence of Cl indemnity Declined letter for previous application in respect of the same or substantially similar study Covering letter GMP certification for manufacturer GMP certification for packer Sample labels Site re certification s Other Mandatory for HDEC Yes Yes No Yes if no at a 8 1 Yes if yes at a 8 1 Yes if p 3 enabled Yes if yes at p 1 5 Yes if yes at r 2 3 1 Yes if yes at r 1 7 1 2 Yes if yes at r 1 7 1 2 Yes if yes at 3 7 2 Yes if yes at a 7 2 No Mandatory for SCOTT Yes Yes Yes Yes Yes if yes at 1 7 2 Yes if yes at 1 7 2 Yes Yes Yes No No Are there any restrictions on the type or size of study documents I can upload Only files smaller than 32MB can be uploaded You can upload any file type you wish into Online Forms but if we can t open it we can t review it For this reason you should only upload common file types such as PDF and MS Office formats Page 16 of 46 8 Transfer a form to another user Transfer a form temporarily You can transfer a form temporarily if you would like another Online Forms user to review and make changes to your form Only one person can edit a form at a given time Do not transfer a form if you
21. S HELP CONTACT US the contact you wish to delete see Your Contacts Database allows you to create and store your colleagues contact details Contacts that are created and saved here can be inserted into any Form wherever you see the insert contact icon 2 You will be asked to confirm the Contacts deletion before the contact is Fiker by First Name actually deleted from the AIABCDEEGHIJKLMNOPQRSIUVWXYZ Name Position Organisation Action database Select OK to continue View Delete View Delete Administrator Ministry of Health View Bee Mr Rohan Murphy Manager Ministry of Health View Delete Add Contact Upload Outlook Contacts Page 8 of 46 Populate contact details into a form Steps Screenshots 1 Once a contact is in your contact database you can quickly fill in icol as contact details in a form by 34 Ao you te lf ie eat clicking on the Add contact i details icon in the form Page 17 of 88 NZ HDEC Form 1 This will open up your contacts database Click on the contact you would like to add into the form 2 This will open up the contact details Click Copy contact details into the form For instructions on how to complete the form please refer to section 6 Page 9 of 46 4 Manage Project Categories This section lists all the available categories you can store your projects in This is similar to directories in a computer filing system Steps 1 Under My Projects click
22. al Ethics Committee approved by the HRC Ethics Committee yes no Tissue banks Does your application involve the establishment or maintenance of a tissue bank ves no Your study requires HDEC review The question below will determine the review pathway appropriate to your study Does your study involve any of the following select all that apply a new medicine an approved medicine being used for a new indication or through a new mode of administration a medical device that is or would be classified as a class IIb class IIl or active implantable medical device by the Therapeutic Goods Administration Health and MINISTRY OF Disability HEALTH Ethics r g Committees Refer to the definition of minimal risk above From 1 January 2013 a study conducted wholly or principally for the purposes of an education qualification will only require HDEC review if e tisanintervention study OR e sabove Master s level Contact details for some Institutional Ethics Committees are available here IEC contacts doc A tissue bank is a collection of human tissue samples stored for potential use in research beyond the life of a specific research project Page 45 of 46 Ob Health and MINISTRY O Disability g Committees TGA a new surgical intervention one or more participants who will not have given informed consent to participate one or more participants who are vulnerable that
23. alian Therapeutic Goods Administrations Australian Requlatory Guidelines for Medical Devices are usually exempt from HDEC review Does this exemption apply to your study yes no Exemption for audits and related activities Audits and related activities as defined in the Ethical Guidelines for Observational Studies are usually exempt from HDEC review i Is your observational study an audit or related activity ves no Does your audit or related activity involve the use collection or storage of human tissue without consent ves no Will the use collection or storage of human tissue without consent in your audit or related activity be entirely in accordance with one or more of the statutory exceptions to the need to gain informed consent set out at section 20 f of the Human Tissue Act 2008 and Right 7 10 c of the Code of Health and Disability Services Consumer Rights 1996 L yes no Exemption for minimal risk observational studies Does your observational study involve more than minimal risk J c yes no A study involves more than minimal risk if potential participants could reasonably be expected to regard the probability and magnitude of possible harms resulting from their participation to be greater than those encountered in those aspects of their everyday life that relate to the study For the avoidance of doubt an observational study always involves more than minimal risk if it inv
24. ames to use n requesting authonsation from distnct health boards and some other organisations evoke utton A thons ab0 types mil ont be enabled once relevant questions have been answered n the form The following electron authonsabons are available for this form type Part annons epon Sponso Not requested Sagned and aho Ms Saran Delgado Not requested Not requestec Electronic Authonsations Festory 18 09 2012 15 19 PM Authonsation gren by Ms Sarah Deigade 18 09 2012 15 18 PM Request for authonsaton recalied by Us Sarah Deigaco How do I authorise my own study If you are the Cl or primary contact person you may need to authorise your own study Steps Screenshots 1 If you need to authorise your ines own study you can do so by ees see ipren None Lad Modified Om 04 10 2012 14 59 15 clicking the Sign button You may seed te obtain authonsations hem other Onine Forms users before submitting your application of balre beginning your stiiy at a locality To request aethorsator smply cick request and enter the suthoneers usemsme which mi sso be ther emai address The sutfhonser mi receve m emal alerting them to Pus request and ashing them to log to Onine Forms to ree Chc amp hate for detass of usernames to use in requesting authorsation fom distinct health Boarts and some athar organisations Aifhorsation types wil orty be enabied once relevant questons have been answered n the form The tefiowrng elect
25. are only seeking authorisations for this please refer to section 10 Steps Screenshots 1 Open the project and click on the Transfer tab Please make sure the form is selected on the left of the screen New Zealas d X Online Forms HOME MYPROJECTS MYCONTACTS HELP CONTACT US s Test application Form Type HDEC Reference None Form Section N A E nte r t h e reci p le n t S e m a i a n d Signatures This form is attached with electronic signatures any changes to the form will invalidate the signatures s u Ci My Project Nawgate Documents Transfer Authonsabon e Submission Post approval click Transfer to User d O J ai F Please enter the recipient s e mail address in the box below EAR ur POS SPO v oras In order to transfer the form t mail address the recipient must have t on the online fo t Please note that the recipient of usn eei e utin iie ere ener tr unire ror vri vi E l To transfer the Form permanently go to My Project Post approva 81 a transferred form must have an dnd TT account with Online Forms first i Automated emails are generated i Teen ve ee advising the recipient and owner of the actions taken at various stages of the transfer 2 You will have access to a read only version of the form while it is in the control of another user signatures an You can retrieve the transferred Naragate Documents ranster Authorisation e Submission Post approval fo r m a t a n y
26. ataset Form for a study approved before 1 July 2012 35 18 Create and submit a Post Approval Form eiiis senate 37 I9 PROG aTeWJoCallll xcti tts bts 40 ATP TON RITE T 42 Page 2 of 46 Overview of Online Forms HDEC or SCOTT Applications Create a new project HDEC or SCOTT V Complete the form V Upload documents V Transfer form to another user if required V Check for completeness V Request authorisations V Submit V Create and submit Post Approval Forms for amendments progress reports etc Page 3 of 46 1 Create an account in Online Forms Online Forms is a website that enables users to complete and submit applications to the Health and Disability Ethics Committees HDECs and the Standing Committee on Therapeutic Trials SCOTT Steps Screenshots 1 Goto Online Forms www ethicsform org nz A ira lesiant Online Forms Then click Create Account in the main menu bar 2 Enter your details choose a za s f j Online Forms password and click Register x raia LOGIN CREATE ACCOUNT HELP CONTACT US Note that the email address you Create Account enter here will be your z username in Online Forms Forename Surname Organisation Ministry of Health Suburb Town E mail Address rohan murphy moh govt nz PostCode User Login Confirm E mail rohan murphy moh govt n
27. ccess to the form click the Retrieve F Include personal message Message from webpage Retri E o qe sure you want to permanently transfer this project to another u Warning selecting OK will permanently transfer the project and you will not be able to retrieve it To permanently transfer this form to another user click the P Include personal message gt gt Permanently transfer ttus form lt lt Transfered From Transfer Action Form Accepted Requested Transfer Page 18 of 46 Find forms that I have transferred to other users or that others have transferred to me Steps 1 Goto My Projects in the main menu and select Transfer Requests Or if you are already in the My Projects screen simply click the Transfer Requests tab Two sub tabs Recipient and Owner will be visible 2 The Owner tab keeps a history of all forms that you have either temporarily or permanently transferred to other users 3 The Recipient tab displays forms transferred to you by other users To accept a pending transfer click on Accept Application 4 Toreturn a form to its owner go into the form and click the Transfer tab Then click the Send back button Once returned the project will disappear from your existing projects Screenshots New Zealand Online Forms for Research MY PROJECTS MY CONTACTS HELP Existing Projects Create New Project
28. ccount opt from the menu at the top of the page Online Forms Features 31 Juy 2012 Updates Delays in introduction of new form types in Online Forms Sethe nfortunately the introduction of new form types in ine Forms wil be sightly delayed We now expect that you will be able to e Log appicabons submitted prior to 1 Juy 2012 using e Minimal Dataset Form 2 Once logged in go to My Projects in the main menu then click Existing Projects and choose the appropriate study New Zealand Online Forms tor Research ar 3 Six project level tabs will be visible Bu URNA Aue Note that the form type HDEC SCOTT or MDF must be selected in the project tree at the left of the screen o e Go to the Post Approval tab Fox rol Forns Post aporoval 169 and click Create a new Post patema 1 Post snommal 170 Approval Form You can create as many post approval forms as needed 4 Click on the title of the Post Approval Form to open it You ONE NPMDNCH MKONNOM M en can do this in either of the two ways indicated on the screenshot Namgate Documents Transfer Authonsation e Submission Post approval Page 38 of 46 Health and b Disability PERA Ethics mm pe g Committees 5 Inthe Navigate tab click on gt Online Forms Filter to begin completing the E Post Approval Form 6 Indicate which type of post CS Online Forms approval item you wish to submit HOM
29. d to submission e Protoce CV ior o Lwdence of screntiic renew e Please obtain the following authonsations You must then go back to the I relevant tabs to complete all mandatory questions and upload documents before requesting yet br a sace sator pnto buon d sho daga he Suoman Han authorisations 3 Once the application is complete n the check for completeness will say Form is complete and ready to submit Online Forms Check for Completeness You should now obtain j Check For Completeness a MM authorisations pactum Proceed to Submission History t sy n electronic submission Cacking the Proceed to Submission Mestory button will also display t Proceed to Submasion History Page 20 of 46 10 Request or Grant Authorisations What is an authorisation Electronic authorisation replaces an ink signature for the Co ordinating Investigator Other Investigators Primary Contact Person Sponsor 3rd Party performing sponsor s duties or functions in NZ Locality and Other on forms generated on the Online Forms system This avoids the need to take or post paper copies of forms to the various individuals who need to authorise the application forms More than one electronic authorisation may be requested at the one time though the persons authorising the form must have an Online Forms account You should obtain authorisations only once you are confident the form is complete see section 9 Please note
30. e contact HOME MYPRONECTS MYCONTACTS HELP CONTACT US you wish to edit My Contacts Your Contacts Database allows you to create and store your colleagues contact details Contacts that are created and saved here can be inserted into any Form wherever you see the insert contact icon Contacts Filter by First Name e AIABCDEEGHIJKLMNOPOQORSIUVWMXYZ Name Position Action View Delete Administrator Ministry of Health Delete Mr Rohan Murphy Manager Ministry of Health View Delete Page 7 of 46 Steps Screenshots 2 Click Edit Details HOME MI PROKCT My Contacts Your Contacts Database allows you to create and store your colleagues contact details E nte r d eta Is a n d cl IC k ii U p d ate Contacts that are created and saved here can be inserted into amy Form wherever you see the insert contact icon 1 to Save changes Contacts Ms Sarah Delgado Title Ms 1 The Terrace Forename Sarah Sumame Delgado Position Administrator Organisation Ministry of Health Suburb Town Wellington Department HDECs Postcode 6011 Summary of qualifications and Country Hew Zealand relevant experise Please declare any general E mail sarah delgado moh govt nz competing interests Telephone 04 8163357 Fax Mobile Phonei AH Delete a contact Steps Screenshots To delete a contact click on My pu Pe Online Forms Contacts in the main menu bar tor Research then click the Delete link by HOME MYPRONECTS MYCONTACT
31. earning ee Mr Rohan Murphy rob murph My A t Logout Page 35 of 46 Complete the MDF by answering the questions in the Navigate tab Click on MDF1 MDF8 to answer Please note that if the dein SE Pas Pena Pepe information you enter in the a Hbi form is different to what we have on file you may be asked to recall your MDF correct the information and re submit The format of the reference number must be identical to what we have on file e g MEC 01 01 01 If you are not the Co ordinating a jaaa Investigator CI for the study the CI will need to authorise the MDF before it can be submitted You can request authorisation from the CI through the Authorisation tab refer to section 10 Please note the CI must have an account in Online Forms to do this In the e Submission tab click EH PENE OENE TE Check For Completeness If your form is complete you can submit it by clicking Proceed to mue Mon Submission History and then z sed BI 0 Check for Completeness click the Submit button that psn remitto mb pte etsy ee o appears below A message confirming submission of your MDF should appear You will receive an automatic m email once your MDF has been registered in the system You can view correspondence from HDECs and SCOTT in the pero RR oe MDF s e submission tab by clicking on the icon in the jo ETUR submission history see section
32. eenic authowsabons are avadabie for thes form type D Status Atheist Hyer Co ontrating imestgator Not requestet Sn Other Investigator Not requested E ad Primary Contact Person Not requested Sporer Net rapeste no sn Thad party periorming sponsors dubes functions m NZ Not requested EL One Na requested ETE 2 Enter your username and ERE Please enter your usemame and password and the details relevant uc passwor an C IC Ign P You may need to ottan authorsat iore beginning yout study at a locality To request authonsation simply cl email address The authonser wil recewe an email aening them to this request and aptang them to log n to Onine Forms to resi Chch here tor detis of username her orgaresations Aithontation types wil only be en Aafthonser Organisation Name or indudual s Name The following eiectromc authonsat Pret authonsatuoo report Lead investigators at Locality thus feld s for Locality mn c S Not requested Not requested Not requested Not requested fiot requested Not requested Not requested Page 23 of 46 l ve been asked to authorise a study what do I do If you receive a request for electronic authorisation with an incorrect research personnel title authorisation type reject the form and immediately notify the owner of the request Steps Screenshots 1 Ifyou have been asked to authorise a study you will receive an email with a link to log 17 77 777 seen autho
33. ests Why can t I delete a project Once a project has been submitted for review it can t be deleted unless you recall it first For instructions on how to recall a project please refer to section 13 Page 31 of 46 16 Set up email notifications for a project Online Forms will notify you the form owner by email when a letter from the HDECs or SCOTT is available about your project You can decide who else will be copied into email notifications by following the steps below Steps Screenshots 1 Open the project and click on the HOME MYPROKCIS MYCONTACIS HEL CONTACTUS Email Notifications tab Note that this project level tab be TP u will only be visible when My n Project iS selected in the project T Please enter recipient s email address in the box below This option is for sending email notifications releating to the project status and committee correspondence tree at the left of the screen Email Addresses to be notified 2 Enter the email address of the HOME MYPROKCIS MYCONTACIS HELP CONTACTUS person who you wish to receive E ak email notifications Form Type H a cs EIE Click Add recipient Hor Please enter recipients email address in the box below This option is for sending ence Email Addresses to be notified 3 You can add as many recipients HOME MYPROKCTS MYCONTACTIS HEP CONTACTUS as you like by repeating step 2 Not named yet
34. etails including your password 3 If you wish to save any changes O Online Forms g you have made to your account details enter your current password and click Save 4 To log out of Online Forms at any ri stage click Logout on the top right of the page Page 5 of 46 3 Create Edit or Delete Contacts Create a contact in the database Your personal contact database is designed to help you if you are filling out many forms and often refer to a contact multiple times Steps Screenshots 1 To add a new contact into your Online Forms personal contact database click x for Research on My Contacts in the main HOME MYPROJECTS MYCONTACTS HELP CONT CTUS z Add New menu bar and choose option ia E ne a Add New um Project Categories oe a New Projects 17 Trensfered Projects 0 Projects Requests for Authonsation Transfer Requests ig Approved Projects 0 ims Old Projects 14 2 Enter contact details and click MM MITER WONNEN HM COTW Add Import contacts from Outlook Steps Screenshots 1 To import contacts from Outlook you must generate an Outlook csv file Go to Contacts in your MS Outlook Select File gt Import and Export from the Main Menu bar A new window will appear Select Export to a File from that window Click Next Select Comma Separated Values DOS Click Next Select the Contacts folder Click Next Select the location where you wish to sa
35. ick the Send Request button Please note that the authoriser must have an account with Online Forms You can request authorisation from as many localities as necessary Page 40 of 46 Health and b Disability SAT u g Committees Steps Screenshots 4 Once the authorisation is given a Raton y dung heu meeps Be paan liaogate Documents Transfer Authonsation green tick will appear next to it An authorisation history at the nive bottom of the page keeps a record of all authorisation requests You can also print an authorisation report for your 18 09 2012 15 18 PM ocalty Request for authorsation recalled by Ms Sarah Delgado Go to http ethics health govt nz applying review research contacts to find contact details for district health boards and some other organisations Page 41 of 46 Health p and UE Disability g Committees Appendix Screening questions HDEC Form The screening questions will help determine whether HDEC review is required for your study They are based on the rules contained in section three of the Standard Operating Procedures for Health and Disability Ethics Committees Please note that not all the screening questions will be enabled as dependency rules apply to these questions e g F will only be enabled if you answer yes in E Screening Question Details Health and disability research Answering no in this question will Will your study aim to impro
36. l have the option to have your application reviewed as soon as possible or as near as possible As soon as possible will be assigned to the next available HDEC meeting regardless of location As near as possible will be assigned by the secretariat to the HDEC that meets nearest to the Cl HDEC applications submitted for expedited review will be assigned by the secretariat to the HDEC nearest to the Cl Page 27 of 46 12 Follow the progress of my submission and view correspondence from HDECs SCOTT In the e submission tab you can monitor the progress of your application through the key stages in the review process and view correspondence from HDECs and SCOTT Steps Screenshots 1 Openthe project and click on the Check for Completeness f 4 G G e Su bm ISSION ta b A check for completness must be performed each time you submit appli 4 Under the section titled Proceed to Submission History Click on the to expand the history Application clo To view correspondence for a Post Approval Form you must go rA uted application if the application is either pending registration into the e submission tab of the Post Approval Form itself not in the HDEC SCOTT or MDF parent form 2 The submission history table will allow you to monitor the progress of your application 3 Letters from the HDECs can be downloaded from the documents table Submission Status ck started 24 08 2012 00
37. olves one or more of the following e oneor more participants who will not have given informed consent to participate one or more participants who are vulnerable that is who have restricted capability to make independent Health and MINISTRY OF Disability HEALTH Ethics r g Committees the information cannot be linked back to the individual s i e This information is de identified Only answer yes in this question if the purpose of your study is to test a low risk class I medical device Page 44 of 46 decisions about their participation in the study standard treatment being withheld from one or more participants the storage preservation or use of human tissue without consent the disclosure of health information without authorisation Please briefly explain why you consider that your observational study involves more than minimal risk 200 words Exemption for some student research Is your study to be conducted wholly or principally for the purposes of an education qualification at or below Masters level ves no Guthrie cards Will your study involve the use of human tissue samples known as Guthrie cards taken as part of New Zealand s Newborn Metabolic Screening Programme ves no HRC funded research Is your study both e funded by the Health Research Council of New Zealand HRC and not able to be reviewed by the HRC Ethics Committee or an Institution
38. on Manage Categories 2 You will see a default folder called New Projects where your projects will be stored To add a new folder click on Add Category 3 To name the new folder you have added click Edit You can delete a folder by clicking Delete but only if you do not have any projects stored in it 4 To move a project into a new folder expand the folder the project is stored in by clicking and tick the project s you would like to move Then select the folder you want to move the project into from the dropdown list at the bottom of the screen and click Go Screenshots New Zealand Online Forms for Research MY CONTACTS HELP CONTACT US ADMIN Create New Project Projects Requests for Authonsation 4 Transfer Requests New Zealand Online Forms for Research Fae HOME MYPROJECTS MYCONTACTS HELP CONTACTUS ADMIN Manage Categories Category name New Projects Edit Delete Move selected forms to category New Projects Go New Zealand Online Forms Y for Research HOME MY PROJECTS MY CONTACTS HELP CONTACT US ADMIN Manage Categories Category name New Projects New Category Add Category Move selected forms to category New Projects v Manage Categories New Projects Not named yet 7 Not named yet 7 lot named yet Not named yet Not named yet Not named yet Not named yet Not named yet Not named yet Not named yet
39. risation as Spon c Piet tec in to Online Forms Mmi 172 j Please authorise my study Please login at https ethicsform org nz to accept this request If you need further help or assistance please e mail us at helpdeskflinfonetica net or phone 0800 634 758 or 64 4 974 7675 E 4 Online Forms Electronic Authorisation Request Online Forms Ms Sarah Delgado Dear Ms Sarah Delgado Regards HDEC SCOTT Form https ethicsform org nz This is a system generated e mail Please do not reply 2 Once you log into Online Forms lt gt Gnine Forms in the main My Projects page wens click into the Requests for Authorisation tab Any outstanding requests for authorisation will be displayed under the Requests tab Click Open Request to review and sign the form 3 Click the Review Requested Form button to check the information in the form in a read only format 4 Navigate through the form by HOME MYPROKCTS MYCONTACTS HELP CONTACTUS clicking the Next and Previous a Testing arrow buttons Form Type HDEC Reference None Form Section RESEARCH AND STUDY TYPE Signatures None After reviewing the form click the Navigate icon and then click into the Authorisation tab again Page 1 of 88 Read Only rr Health and disability research These screening questions will help determine whether HDEC review is r r Or ratin r res for ith an ysabilif E thuee Cor mm equired for yo
40. rotect participants from a significant immediate hazard to their health and safety Temporary halts to the study due to safety concerns Substantial protocol deviations Early termination of a study MINOR AMENDMENTS amendments are not required to be submitted for HDEC review Examples of these include Minor or administrative changes to study documentation Updated versions of the Investigator s Brochure where the study involves a new medicine Changes to the research team including lead principal investigators at particular localities other than the appointment of a new Co ordinating Investigator Changes in funding arrangements except where these may alter the ability of participants to access publicly funded compensation in the event of injury Changes in arrangements for recording or analysing study data or for storing or transporting samples The extension of the study beyond the expected end date given in the application form except where this is related to other changes that are substantial Routine closure of a site Addition of a new site Page 37 of 46 How to create and submit a Post Approval Form Steps Screenshots Pas Online Forms 1 Login to your Online Forms account at www ethicsform org nz Welcome to NZ Online Forms You Can use this site to Submit appacatons to the heatth and disability etfecs commimee 4 Committee on Therapeutic Trials SCOTT ntt selecting the Create A
41. te a form The Navigate tab is available on all forms HDEC SCOTT MDF and PAF It allows you to navigate through the form either by question number or page number Inactive questions are shaded blue and cannot be clicked on Active questions have a white background and clicking on them will take you directly to those questions in the form Certain questions are activated or deactivated depending on your answers to the questions in the form so not all 88 pages of the form will be active The form does not need to be completed in one session as the system will save your progress every time you finish a page For guidance on the HDEC form screening questions please refer to the Appendix on page 42 Steps Screenshots 1 To fill out the form open the d es E m project and go to the Navigate Mur ene OMEN wu ihre tab Click here to begin completing reviewing the form or click on the question number for a specific section 2 This will open up the form HOME MY PROJECTS MY CONTACTS HELP CONTACT US Not named yet To return to the view above click on the Navigate icon To move through the form click on the previous and next arrows or on the page numbers in the These screening questions will help determine whether HDEC review is required for your study They are based on the rules contained in section three of Da h and keah iy Fiho Car centre of the screen the Standard Operating Procedures for Health and
42. the project tree at the left of the screen RESEARCH AMD STUDY NPE MAIN CRITERIA EXEMPTIONS INCLUSIONS HDEC REVIEW HDEC A Administrative section a 1 Title and summary a2 Object phase and design 3 imvestigators 4 Pnmary contact person 5 Sponsor a 6 Localities and participants 2 Click Check for Completeness Eo eme w tor Rasuand s Test application Once the application is complete the check for completeness will say Form is complete and ready Am rane nate Ones Tem Aunt to submit qurenascon E RD n co Proceed to Subenission History u to submit an electron s section allows y ectronic submission Chcking the Proceed to Submission Mestory button will also display the Submission Histor Proceed to Submasion History 3 Click Proceed to O Saline Forms Submission History and then c click on the Submit to HDEC button that appears below Page 26 of 46 Steps Screenshots 4 Once submitted a submission code will be generated and you will be able to track the progress of your application refer to section 12 Can I change my form after submitting No you may not make changes to an application between submission and approval however you may recall or withdraw your study if you would like to make substantial amendments to your application see section 13 To what committee has my application been submitted to For HDEC applications submitted for full review you wil
43. udy If your study has been approved by an HDEC and by SCOTT you will need to submit two MDFs one for HDEC and one for SCOTT Steps 1 Login to your Online Forms account at www ethicsform org nz If you haven t already created an account you will need to do this before you can log in see section 1 2 Once you have logged in go to My Projects in the main menu and click Create New Project 3 Select Minimal Dataset Form in the Project Filter tab Then click on the MDF icon to the left of the page to open the form Screenshots Online Forms A A New Zealand Online Forms b for Research HOME MY PROJECTS MY CONTACTS Existing Projects Create New Project Requests for Authorisation Transfer Requests Manage Project Categories Health ani b Disability Ethics g Committees Online Forms Features w Online access from anywhere 31 July 2012 Delays in introduction of new form types Online Forms HELP CONTACT US b health and disability ethics committees HDECs and the Standing Committee on Therapeutic QC newzealand govt nz No special software needed except your browser and a PDF reader w Special characters support w Contacts database w Helpline answering your questions u need to have the free Adobe PDF Reader installed on your computer Get M ADOSE READE Updates in amp Mr Rohan Murphy rohan_ My Account Logout Getting started E L
44. ue Act 2008 the following e all or any part of a body e whole human organs for example hearts kidneys livers and lungs or parts of them for example heart valves Page 42 of 46 Health and Disability Ethics Committees HEALTH human stem cells or other human cells human blood human bone marrow human hair nails and skin human mucus sputum or urine HDEC review is not usually required for studies in which human Answer yes to this question if tissue is to be used collected or stored where e You have informed consent e informed consent which may including informed to use the tissue and the consent to future unspecified research has been tissue is de identified obtained for such use and tissue will not be made available to researchers in a form that could reasonably Spee one or more statutory be expected to identify the individual s concerned or exceptions apply to the one or more statutory exceptions to the need to gain need to gain informed informed consent set out at section 20 f of the Human consent Tissue Act 2008 and Right 7 10 c of the Code of Health and Disability Services Consumer Rights 1996 Does one or both of these exceptions apply to your study ves no Will your study involve the use or disclosure of health Health information is information as defined by the Health Information Privacy Code e information about the 19956 health of an individual 2 yes including
45. ur study They are based on the rules contained in section three of Maas Don t hesitate to contact us if you d like help answenng these questions or any others in the HDEC form A Health and disability research Will your study aim to improve health and independence outcomes 9 Yes O No Page 1 of 88 Read Only NZ HDEC Form Page 24 of 46 Steps Screenshots 5 Inthe Authorisation tab Click the Authorise Form button to generate an electronic signature Alternatively click the Reject Request button if for some reason you cannot sign the form 6 Enter your username and password Also enter the Authoriser this may be the Organisation Name or Individual s Name and the names of the Lead Investigator s at the Locality this field is for Locality Authorisation only this information appears when you generate an authorisation report Then click the Sign button 7 A history of all electronic authorisations you have previously granted not granted will appear under the Signed tab Page 25 of 46 11 Submit a form Once you have completed the form uploaded the relevant documents and obtained all mandatory authorisations you must submit your application to HDEC or SCOTT Steps Screenshots 1 Open the project and click on the 45 niine Forms e Submission tab Note that this form level tab will only be visible when the form type HDEC SCOTT or MDF is selected in
46. ve health and independence mean this study does not need to be outcomes submitted for HDEC review and the E rest of the form will be disabled Human reproductive research Answering yes in this question will Will your study involve the creation or use of a human gamete a mean your study must be reviewed human embryo or a hybrid embryo by the Ethics Committee on Assisted Reproductive Technology ECART rather than by an HDEC and the rest of the form will be disabled Type of study Is your study B an intervention study An intervention study is a study in which the investigator controls and studies the intervention s provided to participants for the purpose of adding to knowledge of the health effects of the intervention s The term intervention study is often used interchangeably with the terms experimental study and clinical trial an observational study In observational studies the researcher has no control over study variables and merely observes outcomes Will your study involve human participants recruited in their capacity as e consumers of health or disability support services or e relatives and or caregivers of consumers of health or disability support services or volunteers in early phase clinical trials including bioequivalence and bioavailability studies Will your study involve the use collection or storage of human Examples of human tissue include tissue as defined by the Human Tiss
47. ve the exported file Click Next then click Finish Page 6 of 46 Steps Screenshots 2 Click on My Contacts in the A New Zealand main menu bar and choose w Online Forms option Import Contacts from HOME MY PROJECTS MY CONTACTS HELP CONT CT US Outlook Add New i 1 Import contacts from Outlook Click the Browse button to find Your Contacts Database AM olleagues contact details n and select the exported file from Contacts that are created and saved here can be inserted into any Form wherever you see the insert contact icon ra MS Outlook with contacts click MEE Upload Outlook Contacts Open and then click the Upload File button Choose file to upload Select All Deselect All Upload File Cancel 3 To upload the entire list click on the Select All link to ensure that all boxes are checked and Dr Jon Who Hospital X jwho fake com click U pload File Mr Jon Mann Hospital M jon mann hosp com Mr Waine rusev Hospital M w rusev fake com To upload selected contacts use Mr Clive Stefchov Hospital M c_stefchov hosp com the Deselect All link to uncheck Ms Tina Long Johns Hospital S tina lj fake com the boxes and check the boxes to mark the contacts to save then click Save selected contacts Cancel Edit a contact Steps Screenshots 1 To edit a contact click on My pu E Online Forms Contacts in the main menu bar x tr Research then click View on th
48. ven locality in New Zealand it must be authorised by that locality in Online Forms Locality authorisation confirms that the locality is suitable for the safe and effective conduct of the study and that local research governance issues have been addressed Locality authorisations are not mandatory prior to submission You may add a new locality at any time You do not need to submit a Post Approval Form advising HDECs of the addition of a new locality Steps Screenshots 1 Once logged in to Online Forms go to My Projects in the main menu then click Existing Y PROJECTS MY CONTACTS HELP CONTACT US Easting Projects Projects and choose the n j Creste New Project DE Requests for Authorsation the health and disability ethics committees HDECs and the Standing Committee on Therapeutic Trials SCOTT appropriate study uu p 22 ineosere Disability cem Ethics new reakand govt nz g Committees Online Forms Features w Online access from anywhere wv No special software needed except your browser and a PDF reader w Special characters support w Contacts database 2 Once in the project go to the 5 Snina Forms Authorisation tab a Note that this form level tab will only be visible when the form type HDEC SCOTT or MDF is selected in the project tree at the left of the screen 3 Select Locality and click Request Enter the email address of the authoriser and include a personal message if necessary Cl
49. z Country Password eeccccccece Telephone Number Confirm Password eeccecccces Fax Password must be at least 6 characters at ieast 1 of which must be a numb 3 An email containing a web link tee este and an activation code will be sent to the email address you LOGN CREATE ACCOUNT HEL CONTACTUS have entered Activate Account An email containing your activation code has been sent to the account that you registered with Please enter your account activation code in the box below to activate your account O nce you h ave rece ived th e If you are having problems activating and accessing your account please contact our IT help desk activation code click on the web estie fige link enter the activation code and click Submit The text below should appear on screen Click as indicated to log in Your account has been activated Click here to log in Page 4 of 46 2 Loginto my Online Forms account and manage my account details Steps Screenshots 1 Goto Online Forms AA Online Forms www ethicsform org nz Welcome to NZ Online Forms u Can use Tis she tb submit appl adore to the heal and dsabilty ethers commises MOECS and the Stanang Commies or Enter your Online Forms username i e your email pu address and password Click Submit 2 Your screen should look like this Your name and email address appear at the top right of the screen Click on My Account to view or change your account d
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