Archival of Site Master File and ‘Essential’ Documents in the Clinical Trial Secnario

1. When an investigator receives confirmation that a study can be archived,reference should be made to the clinical trials agreement that should specify whether the investigator or sponsor is responsible for archiving the
study.
2. All documentation as defined in ICH-GCP guidelines (section 8.2, 8.3, 8.4) as ‘essential documents which individually and collectively permit the evaluation of the conduct of a study and the quality of the data produced’’ must be retained until notification from the sponsor.
3. Where electronic copies of documents exist, these should be backed up and retained alongside the paper documents.
4. Files and documents relating to a study may be held in other departments,such as Pharmacy or Clinical Radiology. These should be collated with the master site file when the study is archived.
5. One copy of each document should be kept and filed in a bankart box and stored within the clinical trials archives store.
6. All archived material should be stored in a suitable place. The archival location should be restricted to only appropriately delegated individuals,and appropriate quality checks should be in place to ensure the
preservation of the archive. This would include a Risk Assessment for fire,environmental damage, pest control, and ongoing monitoring of these risks. This store may be an internal storage area or a commercial archiving
store.
7. The Trust will nominate an archivist for Clinical trials; this will usually be the R&D Manager.
8. The master site file and other research documents will be held by the PI,or delegate, for 3 years following the last day of the patient’s active followup period.
9. Study documentation will be consolidated to ensure that only one copy of any document is held in the archive store
10. Archived documents should be packed securely in archival boxes. Staples, plastic wallets and paper clips must be removed as these will degrade the records over time.
11. Paper documents must be suitable for long term archiving. For example,faxes or ECG results should be photocopied since the inks used may be prone to fading.
12.The file should be clearly labelled with the name and reference number of the study, sponsor, investigator and date to be archived until. See Appendix A for a copy of label to be used.
13.For commercial studies it is the lead investigators role to identify the storage area. If it is the sponsor’s responsibility, arrange for them to archive study contents as soon as possible.
14. Access to the material should be restricted to the investigator, his/her delegate and the regulatory authorities.
15.Details of the archiving location should be recorded in a location register stored in the R&D Office. See Appendix B. This register should record the name and reference number of the study, Sponsor, Investigator and date to be archived until as well as where the documents are located.
16.Whenever an item is retrieved from archive, the date, item and person retrieving the item should be documented, together with the date returned to archive.

Medical Records:

17. A check should be made that all enrolled patients are flagged before the study is archived.
18. A destruction date will be recorded on the archiving box: the notes should not be destroyed until at least 20 years after the completion of the trial.