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Study Documentation

study documentation

How a research study has been set-up, managed, conducted and reported should be able to be reconstructed (at any time point during or after the study) from the documentation that is filed for that study.  The 'file' where the study documentation is maintained and retained is referred to as the Study/Trial Master File (S/TMF). Maintenance of the Study/Trial Master File (S/TMF) is essential for GCP compliance and for Clinical Trials of Investigational Medicinal Products (CTIMPs) is a legal requirement1.

ICH Topic E6 (section 8) defines the contents of the TMF as ‘essential documents for the conduct of a clinical trial’ and lists them in detail.  Although this guidance specifically relates to CTIMPs (note this is only guidance and not a definitive checklist), Noclor recommends the definitions of what are considered ‘essential documents’ are applied where relevant in non-CTIMP research and documents filed/retained accordingly in a S/TMF.

For research studies sponsored by a Noclor partner the responsibility for managing the S/TMF will usually be delegated to the Chief Investigator (unless otherwise specified by Noclor, for example, where the responsibilities for maintenance of the TMF have been contracted out to a third party for a CTIMP).

For multi-centre clinical trials (where a Noclor partner is sponsor), the Chief Investigator will be expected to provide Investigator Sites with a template index for Investigator Sites Files (ISF) plus the approved study documents, data capture tools, study manual (where applicable) and the study/sponsor SOPs required to conduct at or before site initiation.

Study/Trial Master File Referencing

The Study/Trial Master File (S/TMF) should be clearly referenced on the spine (easily identifiable) with the study short title, unique registration identifiers (sponsor reference as minimum and for CTIMPs the EudraCT ref must also be included on spine), Chief Investigator name and the number of files that constitute the S/TMF (for example file one of five would be File No:1/5) .

 
Study/Trial Master File Set-Up & Maintenance

The Study/Trial Master File (S/TMF) should be set up from the beginning of the study i.e at the design and development stages (to ensure all study work up documents are retained) and then kept up to date at all times. 

In line with Noclor’s risk-adaptive approach to sponsoring research, the Chief Investigator will be a provided with a template S/TMF index that must be worked to where a Noclor partner has agreed to act as sponsor (all documents filed up until this time should be re-filed according the Noclor S/TMF template index).

During the study where documents or files are retained outside of the S/TMF they should be file-noted to detail their location (i.e audit trail of traceability).  The S/TMF files maybe audited by Noclor on request/ad hoc or inspected by the regulatory authority(ies) such as MHRA as notified.

 

Study/Trial Master File Storage

The S/TMF should be stored securely so that only trial staff (and monitor, auditors and inspectors) can access the documentation, located on sponsor premises (unless outsourced to a third party) and archived according to the Noclor Archive SOP after the conclusion of the study.

 

 

[1] Regulation 31A(4) of SI 2004/1031