Information and Instructions for Researchers for the Submission of an Annual Study Progress Report


Nelson Mandela University researchers (staff and/or students) of currently active studies making use of human participants are required to complete and submit a progress report on an annual basis.

Failure to do so may result in the immediate suspension or termination of all data collection activities linked to the study.  In the case of currently active studies which require extension of data collection activities and/or amendments to the study, the relevant form should be completed and accompany the submitted progress report.

Researchers are advised to familiarise themselves with these guidelines and instructions prior to completing and submitting a progress report for review.  Failure to do so might result in a delay in the review and approval of the progress report, thereby impacting on the ability of the study to continue (if applicable).
 

  1. Researchers are advised to have in their immediate possession (NOT for purposes of submission) the following material relevant to the study being reported on while completing the progress report:
    1. Approved version of the application form together with all supporting documentation
    2. Copy(ies) of any requests and approvals for study amendments/extensions/renewals (if applicable)
    3. Copy(ies) of any reports for adverse events (if applicable)
    4. Copy(ies) of previous progress reports (if applicable)
    5. Access to participant consent/assent forms as well as any data that has already been collected
       
  2. Download a copy of the progress report template. The form is intended to be comprehensive in order to assist you with inclusive responses with a view to prevent any delay in the review and approval of the progress report.
     
  3. Researchers are required to familiarise themselves with the instructions and terminology provided on pages 1 – 2 of the progress report template.
     
  4. Complete the progress report in full – refer to the provided definition of terms on page 2 of the progress report template for assistance as and when required.  Provide suitable responses to each item on the progress report. Incomplete or incorrectly completed progress reports might result in a delay of the review and approval process, and ultimately on the ability of the study to continue (if applicable).
     
  5. Complete all required supporting documentation and label each Appendix correctly.
    1. Appendix 1: Study Closure/Discontinuation Report (if applicable) 
    2. Appendix 2: Unreported violations/deviations since last progress report/study approval (if applicable) 
    3. Appendix 3: Amendment Request (if applicable)
    4. Appendix 4: Extension Request (if applicable)
    5. Appendix 5: Unreported adverse events  since last progress report/study approval (if applicable) 
       
  6. Prepare the progress report for submission as per the instructions in the progress report information block.  Incorrect preparation and labelling of Appendices might result in a delay of the review and approval process.
     
  7. Remove the information block (pages 1 – 2) from the progress report.
     
  8. Complete the inventory of Supporting Documentation.
     

Submit the progress report for review to your Faculty Contact Person as well as REC-H (Imtiaz.Khan@mandela.ac.za). Please note with the submission of the progress report, the original copy(ies) of the signed approval letter must be attached. 

 

Deadlines for Submission of Annual Progress Report (2021):

The date for submission of progress reports in 2021 is the 15th November 2021.

Failure to submit the annual progress report by the specified date may result in suspension of the study that has previously been granted ethics approval by either the relevant Faculty Postgraduate Studies Committee (FPGSC) or Research Ethics Committee - Human (RECH).

Kindly note, extension of data collection activities is not an automatic process. Should any researcher require an extension of their approval period, they should follow the process for a Request for Extension of a Currently Active Study.

 

 

1-year approval granted by FPGSC or RECH in the period October 2020 - September 2021*

1-year approval granted by FPGSC or RECH after September 2021*

Data collection still in progress/not yet commenced

 
  1. Progress report (RECH-004 form) and Extension application (RECH-005 form) if ethics approval was granted between October 2020 and January 2021.
  2. Progress report (RECH-004) only if approval was granted between February and September 2021
 Reporting only due in 2022

Data collection completed; possible follow-up engagement with participants

 
  1. Progress report (RECH-004 form) and Extension application (RECH-005 form) if ethics approval was granted between October 2020 and January 2021.
  2. Progress report (RECH-004) only if approval was granted between February and September 2021
 Reporting only due in 2022

Data collection completed; no further engagement with participants

 Progress report (RECH-004 form) and Study Closure/Discontinuation report (RECH-008 form)  Progress report (RECH-004 form) and Study Closure/Discontinuation report (RECH-008 form)

Data collection completed and study closed/discontinued

 Progress report (RECH-004 form) and Study Closure/Discontinuation report (RECH-008 form)  Progress report (RECH-004 form) and Study Closure/Discontinuation report (RECH-008 form)


*Please refer to your letter of ethics approval to confirm the period of ethics approval.