Initialise a New Study - NIHR Clinical Research Network
Contents
1. 1 Locate the required role and click Remove to the right of the role Edit Remove Study Coordinator Modify Study 4817 VERITAS Vasospasm endovascular interventional treatment against standard medical management a trial of cerebral angioplasty for symptomatic vasospasm after aneurysmal subarachnoid haemorrhage VERITAS trial of cerebral angioplasty Audit data Tel Ext Fax Email Study Coordinator Modify Study 7500 MAN_NCtest1 test Audit data Edit Remove Tel Ext Fax Email IHR SC1G Study Coordinator Modify Study 7505 TPM1_testCancer test Audit data Edit ON Tel Ext Fax Email NIHR SC1 googlemail cor Click Remove 2 Click Save The role is removed Copyright 2011 NIHR CRN CC Page 17 of 21 Study Portfolio and Recruitment Initialise a New Study User Guide Appendices Glossary TERM DEFINITION CC Coordinating Centre Chief Investigator My Profile NIHR CRN Public Portfolio Database Record Administrator Role Study Coordinator Study Portfolio amp Recruitment TCRN Topic Copyright 2011 NIHR CRN CC A role associated with access permissions in the UK CRN Portfolio Management System Users with this role can access the Add Amend details of an existing study process in Study Portfolio amp Recruitment for their defined study One of the applications in the UK CRN Portfolio Management System My Profile allows all UKCRN Portal account holders to view an2. 2 Click Study Portfolio amp Accrual Study Portfolio amp Accrual ee Manage Study Portfolio and Upload Accrual Data Click to open Study Portfolio amp Accrual Your Portfolio and Recruitment System home page opens 3 Click Initialise a new study Click Initialise a new study Home Page Windows Internet Explorer Quay GO E htp iitesting ukern org uktpfidefault aspx aa 9 0 lt cool pe am y a gt w k B87 x Poftfolio Database User Guides uxcen Portfolio Database fay A am v Page Of Tools UK Clinical Research Network Portfolio and Recruiment System Back to Portal ssssee Main Menu UKCRN e Home Page Welcome to the UK Clinical ReseArch Network Please choose from the options below tg select what you would like to do Initialise a new study This is the process by which you can create an initial record of a study which the study coordinator manager or delegated person may then populate with data now or at a later date Add amend details of an existing study This allows you to make changes to either a released study or complete a previously started one Search for a study Please enter all or part of the text you are searching for in any of the boxes below as appropriate Study ID Acronym Short name test Study Title Hide most recently accessed studies Your most recently accessed studies Status of aid Short Ti
3. 4 X Pir We de Initialise a El dh gt E Page G Tools UK Clinical Research Network Portfolio and Recruitment System Please select the primary topic for this study and enter the acronym short name by which it is commonly known Use the same title for display Please select Please select the primary topic to populate this list portal ukcrn org u p tal using the application please click here a Local intranet 100 1 Fill out all fields on this page Advice on completing the Basics fields is given below Field Name Acronym or short name Study title Display Title Primary topic Sub topics Description This name is displayed on the study s record in the UKCRN Portfolio and public Portfolio database The acronym or short name must not exceed 100 characters including spaces The name will be checked to ensure that no studies with the same short name acronym exist on the UKCRN Portfolio This is a required field This name is used as the title for the study s record in the UKCRN Portfolio and public Portfolio database It is the title of the study as it appears on the study protocol The study title must not exceed 500 characters including spaces This is a required field This field only appears if you un tick the Use the same title for display checkbox This is a shortened title that will appear as the title for the study record in the public Portfolio databa
4. portal ukcrn org uk pf If you experience problems using the application please click here Internet R 100 The Finish page provides a summary of the study details you have entered 1 Check the details you have entered are correct If you wish to change any details use the tabbed menu on the left side of the page to go directly to the appropriate page You can also use the Next and Previous navigation buttons at the bottom of the page to move between pages 2 Click Finish The study is initialised and is added to the system as a draft The study will not be available on the live UKCRN Portfolio database until further study details are added and the study has been approved by the appropriate Topic Portfolio Manager The Contacts Management page opens E UKCRN Windows Internet Explorer G EJ e http staging ukcrn org uk login MyProfile aspx studyid 7497 E t X Google Pi ww uker 3 A Bl mee Page gt N Tools UK Clinical Research Network Web Portal Logout User Mr Test MAN1 The study has been initialised You should now add the Study Coordinator and optionally add other study roles Contacts management for study 7497 Back to Main Menu staging ukcrn org uk login If you experience problems using the application please click here Local intranet R100 Copyright O 2011 NIHR CRN CC Page 12 of 21 Initialising a New Study Contacts Manageme
5. CONTACTS MANAO IMENT os 13 Access Permissions in Contacts Management ssssssssssesssesesssrresseresssrresseresssreensererssreesseresssreesse 13 Adamo a Cona loa MUI a AR 14 Adang a NEW POSO til 16 Removing a STUDY CONLACT SOIC A A AA AAA 17 APPENDICES Eee esco 18 ES E 18 EED 2 E RAIE EAA E A EEN ante 20 DOCUMENT CONTROL at e aa aaa a Vint a a a ta unde ds el 21 Copyright 2011 NIHR CRN CC Page iii of 21 Study Portfolio and Recruitment Initialise a New Study User Guide Welcome to Study Portfolio amp Recruitment Study Portfolio amp Recruitment is one of the applications in the UK CRN Portfolio Management System hosted on the UKCRN Portal Study Portfolio amp Recruitment has been designed and developed to allow users to manage details of clinical studies on the UKCRN Portfolio and upload recruitment data relating to those studies from any computer with internet access It is a secure system permission to manage study details and upload recruitment data is limited and password protected Purpose This document guides you through the procedure that you should follow in order to initialise a new study on the UKCRN Portfolio Scope This guide relates to the Initialise a New Study process which is part of the Study Portfolio amp Recruitment application in the UK CRN Portfolio Management System The document is intended for users with UKCRN Portfolio Manager or Topic Portfolio Manager roles who wish t
6. Inthe Coordinating Centres field use CTRL left click to select the coordinating centre relating to your topic AN lt is important you use the CTRL key If not any coordinating centres selected this field that are not yet associated with a role will be deselected and removed from the user s account when you click Save 2 Click Save You can now assign the required study role to this person Full Access You will have full access to a person s details if you have either a UKCRN Portfolio Manager role or a Topic Portfolio Manager role and the person you wish to specify as a study contact is associated with the topic you administer Here is an example E UKCRN Windows Internet Explorer DAI Pi we amp Eun gi n y SN am Page Gi Tools O v http 129 11 2 239 login MyProfile aspx studyid 7421 UK Clinical Research Network Web Portal Logout 98 mm User Dr Jo Crawford UKCRN Contacts management for study 7421 Back to Main Menu Search for person 1D name email Crawford or y Select from 6 matches found Dr Jo Crawford j crawford ukcrn org uk 19311 User Guide and Videos Title Dr x First Name Jo Last Crawford Coordinating Centres Name 3 Help i CCRN CC A Preferred Name Login email Mobile r Jo aaa j craw ford ukern org uk oa DeNDRoN CC DRN CC Reasons for using the 70 just needs to login o obtain screen shots MCRN CC system MH
7. National Institute for Health Research Clinical Research Network Coordinating Centre study Portfolio and Recruitment Initialise a New Study User Guide Author Fiona McLaws Version 1 2 Date 19 Jan 2011 Study Portfolio and Recruitment Initialise a New Study User Guide Non Disclosure Copyright O 2011 NIHR CRN CC All rights reserved No part of the material protected by this copyright may be reproduced or utilised in any form or by any means stored in a retrieval system or transmitted in any form or by any means electronic mechanical photocopying or otherwise without the express prior written consent of the NIHR CRN CC Although every care has been taken in the production of this manual it cannot be guaranteed that the information contained herein is without error or omission This manual relates to Study Portfolio and Recruitment Initialise a New Study Copyright O 2011 NIHR CRN CC Page li of 21 Contents Contents WELCOME TO STUDY PORTFOLIO 8 RECRUITMENT cccccsccsscccssccsssccssccsssccssccsscccsccessceescs 4 POUR POS SS nT ET ee ee Te 4 E D A O tara eee sete A 4 RSS UIP TIONS a 4 CQ NI VI schoo II TO 4 GETTING STARTED o oe a 5 ACES Ne 5 A O eee 5 E E E E A 6 INITIALISING ANEW STUDY oesau carona aran r a a EE E AES E 7 OPENING THE INITIALISE A STUDY WIZARD ria 7 FHE BASICS PAGE at 9 THECWNERS HIP RAGE o aa EE EE E ceeded Stands 11 MS E EEE ATE EAEE ETES AE NEEE EE AE AE 12
8. RN CC N Ireland CC Tel Ext Fax Email j crawford ukcrn org uk Stroke Research Network Coordinating Centre Stroke Research Network Coordinating Centre SRN UKCRN UKCRN ntin her ils in Modi lication please click here 2 Local intranet 100 If the person you wish to specify as a study contact is associated with the topic you administer you have full read write access to their main and contact details organisations locations and roles Adding a Contact to a Study To add a contact to a study 1 Inthe Search for a person ID name email box type the ID number name or email address of the person you wish to add Copyright 2011 NIHR CRN CC Page 14 of 21 Initialising a New Study 2 Click Search 3 If more than one match is found click in the Select from X matches found box and select the required person from the dropdown list The person s details are displayed below If you cannot see the required contact in the list the person you require does not exist on the system To add a new contact to the system please refer to Adding a New Person page 16 4 Inthe Organisations section locate the organisation to which the study and intended role relates If you cannot see the person s organisations you do not have permissions to access this person Please follow the instructions in Read Only Access page 13 to gain access If the required organisation is not listed it must
9. alise New Study Duplicate Studies The following study with the same Short Name Acronym has been found You can choose to View the matching study s details Continue Initialising the study you were working on or Add the study to your portfolio Status of Title Portfolio Eligibility Primary Topic Study Record Acronym Short CCRN 382 RA A Prospective multicentre non interventional Adopted commercial ae ToDo ob Add to Portfolio Continue Initialisation If the study is not a duplicate click Continue Initialisation Type an alternative short name or acronym in the Short Name Acronym field and click Next to continue To view a matching study s details check the box next to the required study and click View To add a matching study to your portfolio check the box next to the required study and click Add to Portfolio Add to Portfolio is only displayed if the matching study belongs to a different topic If you select this option an email will be sent to the Study Coordinator or Topic Portfolio Manager for the owning topic requesting that this study be added to your portfolio If the study is added to your portfolio you will have read only access to the data Copyright 2011 NIHR CRN CC Page 10 of 21 Initialising a New Study The Ownership Page Initialise Windows Internet Explorer Quay G gt v E http testing ukcrn org ukipfAnitialisenitialise aspx o M X n gt We de Initia
10. arch for person ID name email fred Search or Add a new person Select from 10 matches found Miss Leslie Frederick leslie frederick royalberkshire nhs uk 807 x User Guide and Videos Title First Name Last Coordinating Name Centres 1 Help CCRN CC A DeNDRoN CC DRN CC MCRN CC MHRN CC IN Ireland CC Preferred Name Login email Mobile No address Reasons for using the system Tel 0118 322 8140 Ext 7449 Fax 0118 322 8425 Email leslie frederick royalberkshire nhs uk You cannot administer this person as they are not associated with your coordinating centre If the person is related to your topic you can add your coordinating centre to the person and add roles You will not be able to administer roles locations or organisations relating to other topics and administrators from other topics cannot administer roles locations or organisation relating to your topic Close window and return to Modify Study If the person you wish to specify as a study contact is not associated with the topic you administer you have read only access to their Main Details except the Coordinating Centres field and Main Contact Details You also cannot view their organisations locations or roles Copyright 2011 NIHR CRN CC Page 13 of 21 Study Portfolio and Recruitment Initialise a New Study User Guide To gain full access to this person you must associate them with the topic you administer To do this 1
11. d field Portfolio Eligibility Indicate the reason why the study qualifies to be included on the UKCRN Portfolio This is a required field The Ownership tab changes from red to black indicating all required fields have been completed 2 Click Next or click Finish in the tabbed menu The Finish page is displayed Copyright 2011 NIHR CRN CC Page 11 of 21 Study Portfolio and Recruitment Initialise a New Study User Guide The Finish Page Initialise Windows Internet Explorer ms y http ftesting ukcrn org uk pf Tnitialise Tnitialise aspx x 911 X Google Pl F A gt we Re Es Initialise x Portfolio Database User Guides uKcRN Portfolio Database 2 D dh i Page Cf Tools UK Clinical Research Network Portfolio and Recruitment System Back to Portal Main Menu Initialise New Study Help Introduction Please confirm the details shown below and click Finish to create the study If you wish to change any information use the tabs to the left or the navigation buttons at the bottom Basics Study Basics Acronym Short name Test Finish Study Title Test January 2012 Primary Topic Dementias and Neurodegenerative Diseases Sub topics Other neurodegenerative disease Ownership Study Ownership Lead Country England Portfolio Country England Owning Organisation DeNDRoN Portfolio Eligibility Adopted non commercial study Finish Previous Cancel
12. d manage their portal account details view existing access permissions and request new permissions to access applications within the UK CRN Portfolio Management System National Institute of Health Research Clinical Research Network The NIHR CRN is managed by the NIHR Clinical Research Network Coordinating Centre NIHR CRN CC and is one of the four networks that comprise the UK Clinical Research Network This is a small set of publically available approved study information from the live UKCRN Portfolio database No specific permissions are required to access this any user can search this database for studies on the UKCRN Portfolio using the Portfolio Search Tool http public ukcrn org uk search A role associated with access permissions in the UK CRN Portfolio Management System Users with this role can access the Add Amend details of an existing study process in Study Portfolio amp Recruitment for their defined study Level of permission for access to specific applications within the UK CRN Portfolio Management System A role associated with access permissions within the UK CRN Portfolio Management System Users with this role can access the Add Amend details of an existing study process in Study Portfolio amp Recruitment for their defined study One of the applications in the UK CRN Portfolio Management System Study Portfolio amp Recruitment allows users with the appropriate access permissio
13. en validated by the NIHR Service Desk Copyright O 2011 NIHR CRN CC Page 15 of 21 Study Portfolio and Recruitment Initialise a New Study User Guide Click Save The specified person will now have the appropriate access to this study in the Study Portfolio amp Recruitment application Choose one of the following o If you wish to open the Modify a Study wizard to continue adding study details click Continue to add further study details in Modify Study at the bottom left of the page The Modify a Study wizard opens with the study details See the Add Amend Details of an Existing Study User Guide for more details on how to proceed This can be accessed from the Help link located above the tabbed menu in the Modify a Study wizard If you do not wish to add any further study details click Back to Main Menu to return to the UKCRN Portal Home page or Logout to log out of the UKCRN Portal Adding a New Person To add a new person 1 First check that the person you wish to add does not already exist in the Portfolio contacts system by following steps 1 to 3 in Adding a Contact to a Study page 14 If the person does not exist click the Add a new person button In the Main Details section type the persons details in the boxes provided If the First Name and Last Name you type match the first and last names of an existing contact the following message will appear in red There is an account already registered wit
14. er or some other appropriate person may then populate with data at a later date Use the navigation buttons at the bottom of the screen to move through the steps to complete this process bold These fields are required as part of the minimum information required to create a study Where the caption has a dotted underline move the mouse over it to see additional information for this field Click this to display a popup calendar to allow date input Y Always show this introduction first he apy On E ee lick bere 2 Local intranet 100 Click to submit a query to the NIHR Service Desk If you wish to submit a query to the NIHR Service Desk click the click here link displayed at the bottom right of any page A New Request page opens Enter the appropriate details and click Submit Request Timing Out For security reasons if you leave the Study Portfolio amp Recruitment System inactive for 20 minutes or more the system automatically logs you out You must re enter your log in details to regain access If you are logged out of Study Portfolio amp Recruitment before completing study initialisation any data you have entered in the Initialise a New Study wizard will be lost Copyright 2011 NIHR CRN CC Page 6 of 21 Initialising a New Study Initialising a New Study Opening the Initialise a Study Wizard 1 Sign in to the UKCRN Portal in the usual way Your UKCRN Portal Home page opens
15. first be added and the relevant location assigned to it before a role can be given To do this please refer to the My Profile User Guide This can be accessed from the User Guide and Videos window in My Profile 5 Click Expand to the right of the organisation to view the person s locations and roles there 6 Find the location where the role will be performed and on the Roles bar immediately below this location click Add role Stroke Research Network Coordinating Centre Stroke Research Network Coordinating Centre SRN Collapse Remove Job title test Edit Locations 4th Floor Leazes Wing Royal Victoria Infirmary Queen Victoria Road Newcastle Upon Tyne GB NE1 4LP Remove Topic Portfolio Manager Tel Ext Fax Email Study Coordinator Modify Study 7416 JNCS2 Jo New Contacts Study 2 Tel Ext Fax Email Click Add role to add a role at this location If you cannot see the Roles bar you must first assign the role s location to the organisation To do this please refer to the My Profile User Guide This can be accessed from the User Guide and Videos window in My Profile 7 Click in the Select role box and choose the appropriate role The role is automatically validated and added to the Roles section If you have assigned this role to a new organisation and location i e one that did not previously exist in the Portfolio database the role will be pending until the organisation and location have be
16. h similar details Check if this person already has a UKCRN Portal account If not continue with adding the person If the Login email address you type matches that of an existing person the following message will appear in red There is already an account with these details The Login email address field will be cleared If this happens it is likely this user already has a UKCRN Portal account From the Coordinating Centres list choose the coordinating centre relevant to the topic you administer If you have permissions to administer industry and non industry users the Type box will be visible beneath the Reasons for using the system field Click in this box and select the appropriate person s type In the Main Contact Details section enter the person s telephone extension and fax numbers in the appropriate boxes Copyright 2011 NIHR CRN CC Page 16 of 21 Initialising a New Study 7 Assign the appropriate organisations and locations to this person For more details on how to do this please refer to the My Profile User Guide This can be accessed from the User Guide and Videos window in My Profile You can now assign a study based role to this person To do this please follow the instruction in steps 4 to 8 Adding a Contact to a Study page 15 Removing a Study Contact s Role If you inadvertently assign an incorrect study role you can remove it and reassign the correct role To remove a study contact s role
17. lise a El da gt Page G Tools UK Clinical Research Network Portfolio and Recruitment System Back to Portal Main Menu Initialise New Study Help Introduction NEEDS UPDATING Please enter the official title for the study and select its portfolio eligibility If you wish to display gt t an abridged title on the portfolio database deselect Use the same title for display and type in the display title Basics Ownership ich the UK CI for Please select Please select Please select Please select portal ukcrn org uk pf using the application please click here a Local intranet 100 1 Fill out all fields on this page Advice on completing the Ownership fields is given below Field Name Description Lead Country This is the country where the study s UK Chief Investigator is based You can choose only one country the lead country can be changed at a later stage if necessary This is a required field Portfolio Country This is the country for whose portfolio this study is eligible You can choose only one country the portfolio country can be changed or additional countries added at a later stage This is a required field Owning This is the name of the main or owning organisation for this Organisations study You can choose only one organisation Other organisations can be added at a later stage but the main owning organisation cannot be changed This is a require
18. ndustry Study Portfolio Reports Validate Roles Validate Organisations and Locations People Administration Local Portfolio Management System LPMS and Local Research Network Finance A role associated with access permissions in the UK CRN Portfolio Management System Users with this role can access all aspects of Study Portfolio amp Recruitment for all studies and topics Page 19 of 21 Study Portfolio and Recruitment Initialise a New Study User Guide Feedback Please report any problems you encounter with Study Portfolio and Recruitment Initialise a New Study If you experience any problems using the application please contact the NIHR Service Desk Team via the link displayed at the bottom right corner of the screen Please give as much detail as you can about the nature and circumstances of the problem Copyright 2011 NIHR CRN CC Page 20 of 21 Appendices Document Control Document Control The controlled version of this document is maintained electronically and accessed via the Help link in the Initialise a Study wizard and the NIHR CRN CC website http Awww crncc nihr ac uk resources systems user guides If you are reading this in printed form or as a local copy you should refer to the Initialise a Study wizard or the website to ensure that you are using the latest version Document Information Revision History 1 1 19 Aug 2011 JC Updated URLs to the Systems User Guides on the CRN CC website Reb
19. nk on the UKCRN Portal Login page https portal ukcrn org uk login If you have a UKCRN Portal account you can use My Profile to request the required role Access may not be immediate and may need to be validated For more information please refer to the My Profile User Guide This can be accessed from the User Guide and Videos window in My Profile Getting Help Additional help resources are available Click the Help link at the top left of the Initialise a Study wizard above the tabbed menu This will open the UKCRN Help amp User Guides window from which you can access the nitialise a New Study User Guide This provides step by step guided assistance through the steps required to create an initial record of a clinical research study on the UKCRN Portfolio The user guide is in PDF format Click ks or Close this window to close the UKCRN Help and User Guides window Copyright 2011 NIHR CRN CC Page 5 of 21 Study Portfolio and Recruitment Initialise a New Study User Guide Click Help to access the user guide and other help items Initialise Windows Internet Explorer woes G 3 v Mtp testing ukern org uk pF Initialise Initialise aspx x 91 X y Y fintiahse gt 6 gt db Ey Page gt E Tos gt UK Clinical Research Network Portfolio and Recruitment System Main Menu Initialise New Study This is the process by which you can create an initial record of a study which the study coordinator manag
20. ns to manage details of clinical studies on the UKCRN Portfolio and upload recruitment data relating to those studies Topic Clinical Research Network A specific disease area for research Examples of topics include cancer stroke blood skin diabetes etc Page 18 of 21 Appendices Glossary TERM Topic Portfolio Manager UKCRN UKCRN Portal UKCRN Portfolio UK CRN Portfolio Management System UKCRN Portfolio Manager Copyright 2011 NIHR CRN CC DEFINITION A role associated with access permissions in the UK CRN Portfolio Management System Users with this role can access all aspects of Study Portfolio amp Recruitment for studies within their defined topic United Kingdom Clinical Research Network A web page that provides access to the core applications within the UK CRN Portfolio Management System A national database of clinical research studies which meet specific eligibility criteria The UKCRN Portfolio comprises the NIHR CRN Portfolio in England the Northern Ireland Clinical Research Network Portfolio the Scottish Clinical Research Network Portfolio and the Clinical Research Collaboration Cymru Portfolio Most study information is password protected and only available to staff working on UKCRN Portfolio studies The suite of applications used to manage details and activities of studies on the UKCRN Portfolio The application suite includes My Profile Study Portfolio amp Recruitment I
21. nt You use the Contact Management page to specify the study contacts and assign study based roles to them You can choose to specify all or some of the study contacts now or at a later date If you do not wish to specify any study contacts now click Back to Main Menu to return to the UKCRN Portal Home page or Logout to log out of the UKCRN Portal You can specify the study contacts at a later date by opening the required study in the Modify a Study wizard and clicking the Contacts Management button in the Contacts field on the Contacts page For more information on this please refer to the Contacts Management User Guide This can be accessed from the User Guides and Videos link on the Contacts Management page AN The Study Coordinator will be unable to access this study or add further details until you have assigned them the Study Coordinator role Access Permissions in Contacts Management Access to a person s details within Contacts Management depends on your role type There are two types of access read only access and full access These are further explained below Read Only Access You have read only access to a person s details if you have a Topic Portfolio Manager role and the person you wish specify as a study contact is not associated with the topic you administer Here is an example UKCRN osx Contacts management for study 7422 Select existing study contacts Select existing study person x Se
22. o and Recruitment System Main Menu Initialise New Study Back to Portal Help Introduction This is the process by which you can create an initial record of a study which the study coordinator manager or some other appropriate person may then populate with data at a later date Basics Ownership Use the navigation buttons at the bottom of the screen to move through the steps to complete this process Finish bold These fields are required as part of the minimum information required to create a study Where the caption has a dotted underline move the mouse over it to see additional information for this field Click this to display a popup calendar to allow date input Always show this introduction first Next cancel portal ukcrn org uk pf j experience problems using the application please click here Local intranet 100 If you do not want this page to be displayed the next time you initialise a new study uncheck the Always show this introduction first box 4 Click Next at the bottom of the page or Basics in the tabbed menu at the left hand side of the page The Basics page is displayed Copyright 2011 NIHR CRN CC Page 8 of 21 Initialising a New Study The Basics Page Main Menu Initialise New Study Help Introduction Basics Ownership Initialise Windows Internet Explorer Quay G gt v e http ftesting ukcrn org uk pf nitialise Initialise aspx e
23. o initialise a new study on the UKCRN Portfolio Assumptions lt is assumed that readers are existing UKCRN Portal account holders and have either UKCRN Portfolio Manager or Topic Portfolio Manager roles in the UK CRN Portfolio Management System Overview This guide describes the steps required to create an initial record of a clinical research study on the UKCRN Portfolio Copyright 2011 NIHR CRN CC Page 4 of 21 Getting Started Getting Started The Initialise a new study process is part of the Study Portfolio amp Recruitment system hosted on the UKCRN Portal You use this process to create an initial record of a clinical research study on the UKCRN Portfolio A wizard guides you through the procedure Once a study has been initialised the study information you have provided is stored in the system as a draft but is not released to the live UKCRN Portfolio database until further information is added and the study is approved Only users with the appropriate permissions can initialise a new study Access Permissions Before you can initialise new study on the UKCRN Portfolio you must first have a UKCRN Portal account and either UKCRN Portfolio Manager or Topic Portfolio Manager roles 2 If you do not have a UKCRN Portal account you can sign up for one at htips portal ukcrn org uk login For more information please refer to the UKCRN Web Portal User Guide This can be accessed from the Help li
24. randed document Please note that we have also started replacing the term accrual with the term recruitment This work is still in progress and until all systems change over to the new terminology the term accrual will continue to appear on parts of the Portfolio system 19 Jan 2011 Updated for CRO444 e Changes to Portfolio Eligibility field options Copyright 2011 NIHR CRN CC Page 21 of 21
25. se instead of the Study Title The text you type here should not exceed 500 characters including spaces This is an optional field This is the main or owning topic to which the study belongs Please select only one primary topic Studies can be jointly supported under a second topic at a later stage This is a required field This is the sub topic under whose remit the study falls You must specify a primary topic before you can select a sub topic Please select only one sub topic at this stage other sub topics can be added after initialisation This is a required field Copyright 2011 NIHR CRN CC Page 9 of 21 Study Portfolio and Recruitment Initialise a New Study User Guide Once you have completed all the fields in this section the Basics tab changes from red to black LM If the Basics tab does not change from red to black on completing the final field not all the required fields have been filled in A study cannot be initialised until all required fields are completed Please review the details on this page and ensure all required fields are populated These are highlighted in bold 2 Click Next or Ownership in the tabbed menu The Ownership page is displayed A If the Matching Studies window opens when you click Next a study with the same Short Name Acronym already exists in the Portfolio database All studies with the Matching Studies oR UK Clinical Research Network Portfolio and Recruitment System Initi
26. tle Portfolio Eligibility Primary Topic Study Record E CCRN 382 RA oe multicentre non interventional aga commercial proc a f j Ad Commercial non NIHR Generic Relevance amp Changes C RC Test Study 4 C RC Test Study 4 CRO444 study Cross Cutting Themes approved E CCRN 444 CKD iaga III Randomised Comparative Open 2 ee commercial Renal and Urogenital tec Fl 3 Tesla MRI in op a sa ere Automatically eligible Neurological Changes h 4 Approve or reject changes to a study This option allows you to release a new modified study to the live UKCRN website Process recruitment data Use this option to upload a file containing recruitment data portal ukcrn org uk pf If you experience problems using the application please click here Internet R 100 The Initialise a New Study wizard opens The Introduction page is the first page you see when you open the Initialise a New Study wizard for the first time This page provides information on the different types of fields and how to move through the steps to complete the process Copyright O 2011 NIHR CRN CC Page 7 of 21 Study Portfolio and Recruitment Initialise a New Study User Guide Initialise Windows Internet Explorer BAX Go v http testing ukern org uk pF Initialise Initialise aspx x 9 X KR amp Initialise p X gt A ia deb Page Of Tools UK Clinical Research Network Portfoli
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