Archives Management
Also separate from the study is the management of the archives.
The archives retain documents and materials so that any future questions about a study can be answered by reconstructing events from the records.
The archives should retain:
Study documents, samples and specimens - click here for more information
Study documents, samples and specimens include:
- The records of all quality assurance inspections; master schedules
- The records of qualifications, training, experience and job descriptions of personnel
- The records and reports of the maintenance and calibration of apparatus
- The validation documentation for computerised systems
- The historical file of Standard Operating Procedures
- Any environmental monitoring records
The archives procedures should be designed to protect the security and integrity of stored material and to ensure effective retrieval.
Click here for some of the controls needed
Good Laboratory Practice requirements include:
- Material retained in the archives should be indexed so as to facilitate orderly storage and retrieval
- Only personnel authorised by management should have access to the archives
- Movement of material into and out of the archives should be properly recorded
