| |
Expectation based on clinical trial GCLP |
Audit observation and recommendations |
Response by the mock trial team |
| Preliminary interview |
Responsibilities and roles of all members of the trial team should be clearly written and understood |
The research team understood their roles and responsibility |
Nil |
| A trial team should also consist of pharmacist to manage study drugs appropriately |
The pharmacist was not included in the mock clinical trial team. |
A pharmacist would be identified for inclusion to the team |
| Document reviews |
Study regulatory binders containing the approved version of the study protocol should be always be situated at study site |
Regulatory binder was available at the study sites |
Nil |
| Each page of the case report forms should be signed off by the principal investigator |
Only the last page of the case report forms was signed off by the principal investigator |
Case report forms were re-designed such each page of the forms contain a section for the principal investigator signature |
| Facility inspection |
Study rooms should have well secured cabinets to ensure safety of participant data and ensure confidentiality |
There was no secure cabinet in the counselling/enrolment room. |
A secured cabinet was provided in line with the recommendation |
| Data storage room should have adequate security measures |
Access into the data storage was not restricted to only relevant personnel |
Additional entry restriction was placed on the data room thus limiting access. |
| Prerequisite study and laboratory equipment and SOP should be available for use |
SOP for Laboratory equipment were available |
Nil |
