Resource Exchange
Search Category: Managing Essential Documents
| CTIMP Trial Master File Contents | |
| Type: Example Form Author: University Hospital Bristol NHS Foundation Trust Keywords: TMF, GCP, Essential documents, Archiving, Close-out, Monitoring, Trial Master File, Filing Structure, Checklist, Audit Additional Detail: Can be adapted for other study types Link Reference: 296 Click here to access the resource |
| GCP compliance in relation to TMFS for management audit and inspection of clinical trials | |
| Type: Paper Author: EMA Keywords: Trial Master File TMF eTMF essential documents GCP inspection archiving scanning retention destruction Link Reference: 293 Click here to access the resource |
| Good Clinical Practice: A Guide to Archiving | |
| Type: Guide Author: Health Sciences Records & Archives Association Keywords: Archiving, TMF, Essential documents Link Reference: 770 Click here to access the resource |
| Study/Trial Master File Structure | |
| Type: Example Form Author: NOCLOR Research Support Keywords: Study/Trial Master File Template Link Reference: 298 Click here to access the resource |
| TMF Location Form | |
| Type: Example Form Author: Portsmouth Hospitals NHS Trust Keywords: Study/Trial Master File Link Reference: 295 Click here to access the resource |
| TMF Reference Model | |
| Type: Website resources Author: A Document & Records Management Community Project Keywords: TMF, Trial Master File, Filing Structure, Essential Documents Link Reference: 769 Click here to access the resource |