- Complimentary CRF Pack
- Patient Information Leaflets (PIL) and Instructions For Use
- Trial Master File
- Patient Recruitment /Retention
- Tabbed Dividers
- Translation Services
- Artworking Services
- Personalisation & Variable‑data
- Global Distribution
- Help & Advice
Clinical Trials Trial Master File
your TMF professionally presented and organised
As every Clinical Trial Administrator (CTA) knows the Trial Master File (or TMF) is the master hard copy of all the details relating to a clinical trial and of the documentation held by the trial's sponsor. More accurately, it is the filing system containing the trial's official documents, notes and patient specific correspondence central to the successful running of each clinical trial.
The Trial Master File exists to demonstrate the reproducibility of the data collected and emphasises the importance of assembling an accurate and complete TMF which is open to scrutiny by both the sponsor's auditing systems and external review bodies alike. As a paper record of all the documents that were collected before, during and after the active phase, it serves as a permanent record of a trial's management and ultimate conclusion.
Typically, the TMF will include more documents on completion than those defined as 'essential' at the outset. So it is important to choose a consistently identifiable (branded) and expandable system that will not only hold everything securely during the trial but also in the review and archive stages as well.
To help organise and present this vital document to all trial staff members and sponsors alike, CIS produce a range of TMF specific custom printed tabbed page dividers (sectional and laminated), peel-able identification labels, permanent labelled document wallets and ring-binders. All items can be collectively personalised for each Clinical Trial & Investigator Site using printed full colour cover/spine inserts and labels.
Call us on +44 (0)1252 260610 or use our simple contact form and one of the team will be in touch to discuss your requirements.