Retention of Records and Materials
Lastly in this Module, we consider the important topic of storage of the study materials. It is the Study Director's responsibility to ensure that the study plan, final report, raw data and supporting material are archived after completion of the study.
This also applies to studies which have been terminated, abandoned, cancelled or withdrawn for a specific reason.
The expectation is that this will happen immediately to ensure vital records are not forgotten or mislaid. Therefore a process to enable archiving to occur promptly is recommended. Remember too that not all records exist on paper. Any computerised data from the study are included in this requirement.
Click here to view other materials pertinent to the study which should be retained in the archives.
Other materials pertinent to the study which should be retained in the archives are:
- Samples of the test item
- Samples of the reference item
- Specimens
Apart from these records and materials, the archives should also retain test facility records as outlined in Module 02 of this course. This includes the records of all inspections performed by the Quality Assurance Programme.
