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health and care research in the UK

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
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Essential documents & templates
Type: Example Form
Author: Portsmouth Hospitals NHS Trust
Keywords: templates; examples, study, master, file, trial
Link Reference: 294
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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
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Good Clinical Practice: A Guide to Archiving
Type: Guide
Author: Health Sciences Records & Archives Association
Keywords: Archiving, TMF, Essential documents
Link Reference: 770
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Study/Trial Master File Structure
Type: Example Form
Author: NOCLOR Research Support
Keywords: Study/Trial Master File Template
Link Reference: 298
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TMF Location Form
Type: Example Form
Author: Portsmouth Hospitals NHS Trust
Keywords: Study/Trial Master File
Link Reference: 295
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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
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