NWU-HREC – North-West University Health Research Ethics Committee NORTH-WEST UNIVERSITY HEALTH RESEARCH ETHICS COMMITTEE ANNUAL MONITORING REPORT 9.1.5.5.1_HREC_AMR_May2019, Version: May 2019
CONFIDENTIAL! This document contains confidential information that is intended strictly and exclusively for the applicant and NWU-HREC. Should this document or parts thereof erroneously come in to your possession, you are requested to destroy it or to return it to NWU-HREC without delay. Unauthorised possession, reading, studying, copying or distribution of this material, or any other form of abuse, is illegal and punishable.

Please complete the form according to the following guidelines: All researchers need to complete Sections A and E. Section B is only completed if the research project is quantitative in nature. Section C is only completed if the research project is qualitative in nature. Section D is only completed if the researchers are making use of previously collected biological samples or data.
SUMMARY OF STUDY
Title of the study	Click or tap here to enter title of the study here.
Ethics Application number:	NWU-
Project Leader/Principle Investigator/Study Supervisor:	Click or tap here to enter PI’s details.
Student Details (Initials & Surname):	Click or tap here to enter Student’s details.

SECTION A: GENERAL INFORMATION AND PROGRESS
Project Head/Principal Investigator/Study Supervisor details
Surname	Surname.	Initials	Initials.	Title	Title.
Department	Click or tap here to enter deptartment.
E-mail	E-mail address.
Telephone	Work	Work telephone number.	Cell	Cellphone Number.

Student Details
Surname	Surname.	Initials	Initials.	Title	Title.
Department	Department.
E-mail	E-mail address.
Details of approved proposal/protocol
Title	Click or tap here to enter title of the study.
Ethics Approval Number	Ethics Approval Number	Risk level	Risk Level.
Approval date	Click or tap to enter a date.	Expiry date	Click or tap to enter a date.
Are there any sub-studies/affiliated studies linked to this project?	Yes	☐	No	☐
If YES, please indicate titles of the sub-study/affiliated study below and mark whether a report has been submitted.
Titles of sub-studies/affiliated studies	Students/researchers included	Report in? (Please attach)
Yes	No
Title of sub-study/affiliated study.	Students/researchers included	☐	☐
Title of sub-study/affiliated study.	Students/researchers included	☐	☐
Title of sub-study/affiliated study.	Students/researchers included	☐	☐

Funding details (Where do you receive your funding from? Please mark with an X)
Internal	☐	National (NRF/MRC)	☐	NIH/US Gov	☐
Industry	☐	International grant	☐	Self	☐
Yes	No	N/A
Were you able to fund your project as initially intended? If not, please indicate here in what way it has changed:	☐	☐	☐

Summary of progress to date
Shortly describe the overall progress to date of the project (500 words): Click or tap here to enter text.
Please describe any ethical issues (both minor and/or major) that may have arisen during the past year (500 words): Click or tap here to enter text.
Describe the research monitoring approach you followed: Click or tap here to enter text.
Yes	No	N/A
Has the level of risk to the participants changed during the past year? If yes, please explain here (new level, reason, how NWU-HREC was notified): Click or tap here to enter text.	☐	☐	☐
Has any new conflict of interest occurred during the past year? If yes, please explain here: Click or tap here to enter text.	☐	☐	☐
Have the research records produced (both hard and soft copies) been correctly maintained and secured as stated in the application? Please explain your system here: Click or tap here to enter text.	☐	☐	☐
If the North-West University Health Research Ethics Committee (NWU-HREC), has provided provisional approval for your project, have you fulfilled the conditions of the provisional approval e.g. approval from the Department of Health, goodwill permission from the school principal etc. and provided the NWU-HREC with these? Please give greater detail regarding the manner in which you have/have not adhered to the conditions of provisional approval provided by the ethics committee: Click or tap here to enter text.	☐	☐	☐

6. Adverse events/Serious adverse events/Incidents (if applicable)	Yes	No	N/A
Have there been any adverse events/serious adverse events/incidents in the project during the past year? Please give the following for each of the adverse events/serious adverse events/incidents that occurred: the date, a narrative overview, how it was managed and how the NWUHREC was notified. 1) Click or tap here to enter text. 2) Click or tap here to enter text. 3) Click or tap here to enter text.	☐	☐	☐
If a data safety monitoring board was part of your planned research have they evaluated the adverse events/serious adverse events/incidents? If yes, please attach a copy of the report.	☐	☐	☐

7. External monitoring (if applicable)	Yes	No	N/A
Has the study been externally monitored or audited e.g. SAHPRA, FDA? If yes, please indicate the name of the agency: Click or tap here to enter text. Please attach a copy of the report.	☐	☐	☐

SECTION B: QUANTITATIVE STUDIES
8. Enrolment of participants
Total number of participants planned to be included in the project.	Insert
Actual number of participants enrolled in the project.	Insert
Number of participants that withdrew from the project out of own choice. Please provide reasons here for participants’ withdrawal: Click or tap here to enter text.	Insert
Number of participants withdrawn by primary investigator, due to adverse events/serious adverse events/incidents/other reasons. Please provide reasons here for these withdrawals: Click or tap here to enter text.	Insert
Number of participants lost to follow-up (if appropriate). Please explain here why they were lost: Click or tap here to enter text.	Insert

SECTION C: QUALITATIVE ANALYSES
9. Methods used
How many participants have been enrolled to date?	Click or tap here to enter text.
Yes	No	N/A
Has data saturation been reached in this project?	☐	☐	☐
Please give an overview of the methodology used to determine the indicated data saturation: Click or tap here to enter text.
Number of participants that withdrew from the project out of own choice. Please provide reasons for participants’ withdrawal:	Insert
Number of participants withdrawn by the primary investigator due to adverse events/serious adverse events/incidents/other reasons. Please provide reasons for these withdrawals: Click or tap here to enter text.	Insert
Number of participants lost to follow-up (if appropriate). Please explain why they were lost: Click or tap here to enter text.	Insert

SECTION D: USE OF PREVIOUSLY COLLECTED BIOLOGICAL SAMPLES OR DATA
10. Biological sample analysis
Total number of previously collected samples that were planned to be used.	Insert
How many actual samples have been examined?	Insert

11. Databases	Yes	No	N/A
Was the database you received anonymised? Describe the process: Click or tap here to enter text.	☐	☐	☐
Was the database you received password protected?	☐	☐	☐

SECTION E: PROJECT AMENDMENTS AND STUDY STATUS
12. Amendments	Yes	No	N/A
Has the study been amended or changed during the past year?	☐	☐	☐
Amendments	Date
Click or tap here to enter text.	Click or tap to enter a date.
Click or tap here to enter text.	Click or tap to enter a date.

13. Status of study	Yes	No	N/A
Has the study been completed and does this serve as your final report?	☐	☐	☐
Has this project been terminated? If so, please indicate the date, reason for termination and when the NWUHREC was notified: Click or tap here to enter text.	☐	☐	☐
Does the project have to continue in the following year?	☐	☐	☐

14. Signature
By signing this document, I certify that the information provided is accurate and complete.
Signature by the primary investigator	Date	Click or tap to enter a date.

Some sections of this document have been adapted from similar HREC documentation of the University of Stellenbosch and the University of the Cape Town.

Original details: (23239522) G:\My Drive\9. Research and Postgraduate Education\9.1.5.6 Forms\9.1.5.5.1_HREC_AMR_May2019.docm
7 May 2019

File Reference: 9.1.5.5.1