Trial master file

The sponsor and investigator, as appropriate, must retain all essential documents relating to the trial for at least 5 years after its completion. Documents should be securely archived, with restricted access to maintain subject confidentiality. Collectively, these constitute the Trial Master File, and facilitate any audit and evaluation of 

---

Figure 5.5 Essential documentation for a Trial Master File.

It may be useful to remind the recipients of the confidential nature of audit reports which means that they should not be made publicly available or distributed to persons outside the company. Regulatory authorities should not routinely be provided with audit reports. Audit reports should be securely filed (ideally with the QA department) and not included in the Trial Master File (TMF). 

Detailed guidelines on the trial master file and archiving to implement the directive on Clinical Trials on medicinal products for human use. June 2002... 

Detailed guidelines are available for CT documentation constituting the trial master file (TMF) and archiving (11), qualifications of inspectors (12) and inspection procedures (13) to verily compliance are in accordance with published procedures laid down in Article 21. 

Products/technologies This contract research and development group offers GMP production Drug Master Files validation of analytical methods multistep organic synthesis development and consultancy services, such as during clinical trials. 

Sooner rather than later, CTD-formatted dossiers should also be made acceptable for other types of products (for example generics, line extensions, herbals, radiopharmaceuticals and blood products). Also, applications for clinical trials (for example CTX in the UK, IND in the USA), as well as applications for variations, and Drug Master Files could be formatted according to the CTD guideline. However, before this becomes reality, national regulations and guidelines need to be adapted accordingly. 

Records are kept of when a sample was collected, the method of collection, who collected the sample, what the elapsed time was between harvest and freezing, the conditions under which it was stored, how it was shipped to the laboratory, and when it was shipped. When a sample arrives at the laboratory, the condition of the sample is checked and recorded. Then the information on the sample bag (sample number, application rate, preharvest interval, etc.) is compared to the trial information sheets which are submitted along with the samples. Any omissions or discrepancies are corrected at that time. If there is an omission or discrepancy that cannot be easily corrected by a telephone call from the sample processing laboratory to the field scientist, the study director is notified. The study director must make the decision about the validity of the sample and put a note in the data file explaining how the problem was corrected or that the problem could not be corrected and the trial is to be abandoned. If the trial is dropped, Quality Assurance is notified, the trial is deleted from the active Master Schedule, and an explanation is put in the study file. 

---