CIRB Guidelines: Conversion of Paper Studies into ishare Studies

Transcription

1 CIRB Guidelines: Conversion of Paper Studies into ishare Studies 1. Introduction ishare e-cirb was rolled out in September The ishare was fully developed in December CIRB has processed more than 3500 studies in ishare. To streamline the submission and review processes, a conversion exercise will commence from 1 March 2018 to convert paper studies which are on-going into ishare studies. 2. Will all paper studies be converted? Studies approved by CIRB through hardcopy with Expiry Date from 1 August 2018 to 31 July 2019 need to be converted into ishare studies. However, conversion to ishare study will not be required if the study is projected to complete within a year from the submission of the Study Status Report. Please submit a hardcopy Study Status Report as per current submission process. CIRB will consider granting the last renewal via paper submission. No further renewal would be granted if the studies couldn t be completed as stipulated in the Study Status Report. 3. What is the process? The Principal Investigator is to submit a new application based on the approved protocol together with a Study Status Report via ishare and ensure that the application form reaches CIRB at least two months before. The application will be reviewed via the continuing review procedure. To help CIRB differentiate between a new application and a previously approved paper study, please enter the following information in the application form: Question A1 Protocol Title Information to be included To include the existing CIRB Reference Number (XXXX/XXX/X) in front of the Protocol Title. E.g. (2012/012/B) Relationship between dietary habits and age CIRB Review fees will not apply to the ishare applications submitted for the conversion exercise. 4. What is the timeline? Reminder notifications will be sent out based on of the approved paper studies. 5 months from CIRB will send an to the Principal Investigator informing him/her of the conversion exercise. 4 months from If there is no submission of Study Status Report for study completion/ withdrawal/termination or submission of an ishare application for the conversion of paper study, a second reminder of the conversion exercise and Expiry Date will be sent. Version: 7 March 2018 Page 1 of 5

2 3 months from 2 months from 1 month from the Expiry Date If there is no submission of Study Status Report for study completion/ withdrawal/termination or submission of an ishare application for the conversion of paper study, another reminder of the conversion and Expiry Date will be sent. An ishare application together with the Study Status Report should have reached CIRB for review. If CIRB have yet to receive the ishare application and Study Status Report for the conversion, another reminder will be sent. This will be the final notification. 5. Conversion Self-Checklist Please refer to Annex A. 6. Info Sessions To facilitate the Conversion exercise, Info Sessions have been planned for the following dates. We encourage the Investigators, Study Coordinators and Research Administrators to attend. No Date Time Academia Registration Link 1 13 Mar 2018, Tue 9.00am 10.00am L1-S Mar 2018, Tue 4.00pm 5.00pm L1-S Mar 2018, Thu 9.00am 10.00am L1-S Apr 2018, Thu 4.00pm 4:.30pm L1-S2 Registration Open (Click here) 5 24 Apr 2018, Tue 9.00am 9.30am L1-S2 Registration Open (Click here) 6 10 May 2018, Thu 9.00am 9.30am L2-D1 Registration Open (Click here) 7 7 Jun 2018, Thu 9.00am 9.30am L2-D1 Registration will open in April 8 12 Jul 2018, Thu 9.00am 9.30am L2-D1 Registration will open in April 9 16 Aug 2018, Thu 9.00am 9.30am L2-D1 Registration will open in April 10 6 Sep 2018, Thu 9.00am 9.30am L2-T1 Registration will open in April Oct 2018, Thu 9.00am 9.30am L2-T1 Registration will open in July 12 8 Nov 2018, Thu 9.00am 9.30am L2-D1 Registration will open in July 13 6 Dec 2018, Thu 9.00am 9.30am L2-D1 Registration will open in July 7. Contact Us For study specific enquiry, please contact the respective Board which approved your studies. Board A chia.joo.yi@singhealth.com.sg Board B yeo.qin.yi@singhealth.com.sg Board C leow.boon.hwi@singhealth.com.sg Board D phyllis.tham.j.h@singhealth.com.sg Board E yee.ai.sin@singhealth.com.sg Board F huang.churou@singhealth.com.sg For general enquiry, please contact CIRB at irb@singhealth.com.sg. Version: 7 March 2018 Page 2 of 5

3 Annex A Self-Checklist: Conversion of Paper Studies into ishare Studies (A) Before creating an application on ishare No Items Check 1. Does of your approved paper study fall between 1 August 2018 and 31 July 2019? 2. Would your study continue beyond one year from? Conversion to ishare study will not be required if the study is projected to complete within a year from the submission of the Study Status Report. Please submit a hardcopy Study Status Report to inform CIRB of the study completion/ withdrawal/termination or request for renewal (maximum of one year will be granted and non-extendable) to complete the study. Definition: Data analysis only The remaining research activities are limited to data analysis of identifiable data. (If the data analysis involves only unidentifiable data, the study may be said to be completed.) Completed There will be no more research activities, including contact with participant or any data analysis of identifiable data. (For multi-centre studies, the study may be said to be completed at the sites when no further data will be collected from the sites, regardless of whether the global study has been completed or not.) 3. This is not an exemption study. Conversion is not required for exempted studies. 4. Do you have the latest approved application or protocol and study related documents? The ishare application should be based on the latest study documents approved by CIRB. With the documents at hand, you would have the necessary information to fill up the ishare application. Other than changes to the Study Team Members, and changes made to the Informed Consent Documents due to Human Biomedical Research Act, no other amendments are allowed during this conversion exercise. 5. Do you have the list of Study Team Members (PI, Site-PI, Co-Investigator and Study Team Member)? 6. Do you have all the Study Team Members CVs and CITIs? Version: 7 March 2018 Page 3 of 5

4 7. Do you have the GCP certificates of your PI and Site-PI? This is applicable to Clinical Trials only. 8. Do you have the latest approved relevant documents to be uploaded on ishare? The following is not an exhaustive list. Some documents may not be applicable to your studies. The documents required depending on the study nature. a. Participant Information Sheet (PIS) and Consent Form - For studies which are still in the recruitment phase, please ensure the necessary elements required under the Human Biomedical Research Act have been included, e.g. witness requirement. - If you have amended the PIS and Consent Form, please submit both the clean and tracked versions. b. Translated Participant Information Sheet and Consent Form c. Data Collection Form d. Visit Schedule e. Patient Diary f. Investigator Brochure 9. Have you filled up the Study Status Report for the renewal of ethics approval for the study? This must be uploaded under Other Attachments. Otherwise, the application form will be returned to you and this may cause unnecessary delay in the review of your renewal request. If your study meets the requirements 1-3 and you have the necessary documents for items 4-9, you are ready to submit an application on ishare to convert a paper study. Version: 7 March 2018 Page 4 of 5

5 (B) Preparing and submitting an ishare application No Items Check 1. Have you included the existing CIRB Reference Number before the Protocol Title in A1? E.g. (2012/0012/B) Relationship between dietary habits and age 2. Are the Study Team Members department and institutions added correctly? Please ensure the department and institution are correctly reflected so that the application could be routed to the correct HOD/DR and IR for endorsements. If you are unable to find the Study Team Member with the correct appointment, please get him/her login to ishare and update the user profile by clicking his/her name at the top right of the landing page. For newly added Study Team Members, they should not carry out any research activities until the application is approved. 3. For F15 Estimated Start Date, you may choose the earliest possible date. The system does not allow selection of an earlier date. 4. For H6 Recruitment Start Date, you may choose the earliest possible date. The system does not allow selection of an earlier date. For studies where recruitment has been completed, the start and end date do not have to be selected. Please indicate in the H6 text box that the recruitment has been completed and the recruitment period. 5. Have you uploaded the completed Study Status Report under Other Attachments? 6. Has the PI declared? Once the PI declared, the submission will be routed to Site-PIs (if applicable), RDO, DR and IR for endorsement. Please allow ample of time for the endorsement process. The application form will reach CIRB once the IR(s) has endorsed. Version: 7 March 2018 Page 5 of 5