5. Progress report

Progress reporting is required to secure continuation of ethics approval. You are usually required to report once a year, although shorter reporting intervals may be indicated for high risk studies. 

You should submit a progress report at least one month before the stipulated deadline. This is to avoid a lapse in ethics approval while research activities are still ongoing.

If you missed the deadline, you should contact the ethics committee immediately to request for an extension of approval, then submit a progress report as soon as you can. 

In a progress report, you are typically required to state: ^(15,22)

your study’s current recruitment status the number of non-compliance incidents that you have reported the number of SAEs that you have reported any unreported protocol changes, non-compliance incidents and adverse events any new information that might affect the risk assessment of your study

If the ethics committee has no concerns, the report will be filed and no further action required. Further review and action may take place if a study has not enrolled any subjects, has serious non-compliance issues and/or multiple SAEs.

The NPRA and MDA also have their own progress reporting requirements for drug trials and medical device research. ^(11,13)

6. Early study termination report →