CIRB STUDY STATUS REPORT FORM

Please complete all applicable sections andsubmit the report to the CIRB at least twomonths before the expiry of the ethics approval for the study.

1. CIRB Reference No: / Text Field
2. Protocol Title: / Text Field
3. Principal Investigator: / Text Field
4. Designation/Department/Institution: / Text Field
5. Request to CIRB(select one option from either (a) Renewal OR (b) Closure)
a. I would like to request for renewal of IRB approval.
Study Status:
Not yet initiated / No research-related activities have been performed since first approval.
Please state reason(s): Text Field
Estimated Start Date: Text Field
Ongoing / Research-related activities are still being performed.
Estimated Completion Date for the study: Text Field
Long-term follow-up / The research is permanently closed to the enrollment of new participantsAND all participants have completed all research-related interventions AND the research remains active only for long-term follow-up of participants.
Estimated Completion Date for the study: Text Field
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.)
Estimated Completion Date for the study: Text Field
Others / Please specify: Text Field
b. I would like to inform CIRB that the study is closed.
Study Status:
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.)
Date of Completion: Text Field
Withdrawn / The study is stopped before site initiation. Date of Withdrawal: Text Field
Please state reason(s) for Withdrawal. Text Field
Terminated / The study is stopped after site initiation. Date of Termination: Text Field
Please state reason(s) for Termination. Text Field
6. SingHealth Recruitment Information:
NOTE: Please complete EITHER Section i or ii.
Section i -For studies involving participants recruitment:
For multi-site studies, please provide the information below for each study site.
Name of Institution: / Select SiteCGHHCAKKHNCCNDCNHCNNISGHSHPSNECIMUOthers / Select SiteCGHHCAKKHNCCNDCNHCNNISGHSHPSNECIMUOthers / Select SiteCGHHCAKKHNCCNDCNHCNNISGHSHPSNECIMUOthers / Select SiteCGHHCAKKHNCCNDCNHCNNISGHSHPSNECIMUOthers / Select SiteCGHHCAKKHNCCNDCNHCNNISGHSHPSNECIMUOthers
If “Others”, please state
name: / Text / Text / Text / Text / Text
Proposed Recruitment Target:
Total No. of Participants
Enrolled:
Total No. of Participants Actually Recruited:
Total No. of ParticipantsWho
Have Completed Study:
*Total No. of Participants
Withdrawn from Study:
* Please state the reason(s) for each participant’swithdrawal from study. Please attach a separate page if there is insufficient space:
Text Field
Section ii -For studies involving the use of human biological samples/ records ONLY:
For multi-site studies, please provide the information below for each study site.
Name of Institution: / Select SiteCGHHCAKKHNCCNDCNHCNNISGHSHPSNECIMUOthers / Select SiteCGHHCAKKHNCCNDCNHCNNISGHSHPSNECIMUOthers / Select SiteCGHHCAKKHNCCNDCNHCNNISGHSHPSNECIMUOthers / Select SiteCGHHCAKKHNCCNDCNHCNNISGHSHPSNECIMUOthers / Select SiteCGHHCAKKHNCCNDCNHCNNISGHSHPSNECIMUOthers
If “Others”, please state
name:- / Text / Text / Text / Text / Text
Proposed Target:
Number of Samples/Records studied
7. Description of ParticipantsEnrolled
  • Did you enrol any of these categories of participants in this study?
Not Applicable
No
Yes – Please tick all applicable boxes below.
Non-English Speaking Participants / Pregnant Women, Foetuses or Neonates
Prisoners / Cognitively Impaired Persons
Children
  • How did you conduct the consent process with these categories of participants?
Text Field
8. Report on Research to Date:
  1. Did you encounter any problems relating to ethical issues?
No
Yes – What were the problems and what did you do about them?
Text Field
  1. Did you comply with the approved consent procedures and documentation?
No – Please explain the reasons for the deviation.
Text Field
Yes
Not Applicable
  1. Please state the document version number and/or version date of all the consent documents being currently used at the study site(s) if applicable.
Text Field
  1. What measures are being taken to protect confidentiality of research data? (e.g: Where are the paper/electronic records stored? Are they are access-controlled? Has there been any breach of the confidentiality of the research data?)
Text Field
  1. Are there any unanticipated events involving risks to participantsor others (including serious adverse events) at your trial site?
No
Yes – Please provide details.
(For all local SAEs, please submit a tabulated summary with the following information: event, onset date, causality assessment, nature and outcome)
Text Field
  1. Are there any DSMB reports, evaluation reports of study-wide adverse events, interim findings, recent literature, or any other information that may affect the risk/benefit ratio of this study?
No
Yes – Please submit the reports with this Study Status Report.
  1. Has anything occurred since the last CIRB review which may have altered the risk/benefit relationship?
No
Yes – If ‘Yes’, pleaseprovide a current assessment of the risk/benefit relationship of the research based on results, internal and external adverse events and other factors. Also, in your opinion, should any changes in the consent form be made based on these results?
Text Field
  1. Please provide relevant information (including those previously submitted at the last renewal), especially information about risks associated with research.
Text Field
  1. Please provide a summary of your research findings (e.g interim analyses / multi-centre trial reports etc.).Please also submit final analyses and conclusions when they are ready, but not more than 3 months after completion.
Text Field
  1. Have you published your research findings?
No
Yes – Please provide details (e.g. report, dissertation, thesis, journal article, book, etc). Include details such as where it has been published (e.g. name of journal, book chapter, etc).
Text Field
  1. Have there been any complaints about the research?
No
Yes – Please provide details of the complaints.
Text Field
9. Declaration of Principal Investigator:
For a Multi-centre study, only the corresponding PI needs to sign this page.
I confirm that the information submitted in the above study status report is true and accurate at the date of submission of the report.
I declare that there are no conflicting interests for any of the research personnel participating in this research study (Important: If there has been a change in financial interest held by you or any of the research personnel, please complete Annex B – Conflict of Interest Declaration Form for each individual having the conflict).
______/ ______
Principal Investigator’s Signature / Date
Full Name: / Text Field
Institution: / Choose from listChangi General HospitalHCAKK Women's and Children's HospitalNational Cancer CenterNational Dental CenterNational Heart CentreNational Neuroscience InstituteSingapore Eye Research InstituteSingapore General HospitalSingapore National Eye CentreSingHealth PolyclinicsOthers
Department: / Text Field
CIRB Study Status Report Form Version 8, 20 Jun 2017 / Page 1 of 4
This Page is for information only and need not be submitted.

Guidance on using the CIRB Study Status Report Form

Important
While the CIRB will make every effort to remind Principal Investigators, it is their responsibility to submit the Status report in a timely manner. Please note that if the Study’s CIRB Ethics approval expires, prospective research data cannot be collected, and no procedures that are being performed for the purposes of the study may be conducted until the Status report is reviewed and approved.
Note
The following study personnel should be listed as study team members* and submitted for CIRB review and approval. The study team members should only carry out research-related activities upon obtaining approval from CIRB. Please submit the Changes to Study Team Members Form for the addition/ removal of study personnel. This applies to studies approved through hardcopy submission.
  • Co-investigators - Members of the research/ clinical trial team designated by the Principal Investigator to perform study-related procedure and/or make important research-related decisions.
  • Study Team Members - Personnel responsible for the design, conduct or reporting of the research.
  • All personnel who have a responsibility for the consent process and/or direct data collection for the study must be listed as study team members (e.g. Co-investigators and Study Team Members).
*The PI and/or site PI should determine if the study personnel meets the definition of study team members (Co-investigators and Study Team Members).

The CIRB Study Status Report Form is used for:

  • Renewal of Approval (report to be submitted to CIRB at least 2 months prior to expiry date)
  • Study Completion (report to be submitted to CIRB within 30 daysof completion)
  • StudyWithdrawal/ Termination (report to be submitted to CIRB within 7 days of termination)

Form Completion Guidelines

  1. CIRB Reference No – Please state the CIRB reference number as stated in the approval letter.
  1. Protocol Title – Please state the protocol title.
  1. Study Status:
  2. Not Yet Initiated - No research-related activities have been performed since first approval. Please provide reasons.
  3. Ongoing - Research-related activities are still being performed.
  4. Long-term follow-up- The research is permanently closed to the enrolment of new participants AND all participants have completed all research-related interventions AND the research remains active only for long-term follow-up of participants.
  5. Data analysis only – The remaining research activities are limited to data analysisof identifiable data.(If the data analysis involves only unidentifiable data, the study may be said to be completed.)
  6. *Completed - There will be no more research activities, including contact with participant or any data analysis of identifiable data. Please indicate the study completion date.
  7. Withdrawn – The study is stopped before site initiation.
  8. Terminated – The study is stopped after site initiation.
  1. Recruitment Information:
  2. Proposed Recruitment Target: Recruitment number indicated in IRB application.
  3. Total No. of Participants Enrolled:Total number of participantswho have signed an informed consent form; or who gave verbal consent on a study conducted under a waiver of documentation of consent.
  4. Total No. of Actually Recruitment: Total number of participantsenrolled minus totalnumber of screen failures.
  5. Total No. of Participants Who Have Completed Study: Total number of participantswho have completed all interventions and follow-up.
  6. Total No. of Participants Withdrawn from Study:Total number of participantswho consented to participate in research, but later discontinued their participation in research at any point for various reasons (e.g. serious adverse events). This does not include screen failures.

* 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.

Submission Requirement
1 signed original
  • Postal Address:SingHealth CIRB Secretariat

Singapore Health Services Pte Ltd

168 Jalan Bukit Merah #06-08

Tower 3, Connection One

Singapore 150168

CIRB Study Status Report Form Version 8, 20 Jun 2017