Forms, Templates and Guidance documents

The list below contains the FRMs, TPLs and GDs which are referenced in the SOPs.

Forms (FRM) | Templates (TPL) | Guidelines (GD)

 
Documents available in Alphabetical order HERE

Forms (FRM)

FRM002 Data Amendment
FRM003 Adverse Events Reporting Sponsor Responsibilities
FRM004 Adverse Event Reporting Investigator Responsibilities
FRM005 Adverse Event Reporting (Not SAE, SAR, SUSAR)
FRM007 Adverse Events Reporting (SAE, SAR, SUSAR)
FRM012 Version Control of Trust Approved Documents
FRM013 Risk Assessment Tool
FRM014 Resuscitation Trolley Checklist
FRM015 Database Training Data Entry Training
FRM016 Database Validation Specifications 
FRM017 Database Lock and Close Down 
FRM018 Database Testing/Validation and Acceptance
FRM019 Database Unlock Request
FRM020 Database Using Formic Guidance
FRM021 Sponsor Site File Index 
FRM022 Regulartory Green Light Checklist for NON Papworth Sponsored Trials
FRM023 Trust Approval Green Light Checklist (Papworth Sponsored Studies) 
FRM024 Risk Assessment of Papworth Sponsored CTIMP Products
FRM025 Audit Report
FRM026 Data Query 
FRM027 Monitoring Report (monitoring source data & case report forms)
FRM028 Memorandum of Understanding (Papworth sponsored studies)
FRM029 Codebreak (Unblinding) Randomised Clinical Trial Request (same form as unblinding (codebreak randomised clinical trial request)
FRM030 Codebreak Test procedure
FRM031 Drug Accountability Log
FRM032 Subject Specific Drug Accountability Log Template
FRM033 Drug Recall Handling
FRM035 IMP Under Quarantine (same form as drug CTIMP under quarantine)
FRM036 IMP Quarantine File Log (same form as drug (CTIMP) quarantine
FRM037 OpenClinica Design Changes
FRM038 Protocol Non-Compliance
FRM039 OpenClinica Data Amendments
FRM040 Memorandum of Understanding (Non-Papworth sponsored studies)
FRM041 SMPc Review Checklist
FRM042 Delegation Log (Project Management -CPMs) 
FRM043 Tissue Bank Application Form
FRM044 Pharmacy Monitoring Form

FRM045 Development Safety Update Report (DSUR)

FRM054 Site Visit Log
FRM059 Archive Retrieval Form
FRM060 Certificate of Destruction
FRM061 R&D Audit Certificate
FRM062 R&D Audit Notification Letter
FRM063 Pharmacy Directorate Approval
FRM064 Pathology Registration Form
FRM065 Radiology Approval Form
FRM066 Pathology Registration Form
FRM067 Systems Access and Code of Conduct
FRM068 Site File Index

 

Templates (TPL)

TPL003 CTIMP Protocol template
TPL007 File Note
TPL010 Monitoring Report
TPL013 Monitoring Visit Confirmation Letter
TPL015 Participant Information Sheet and Informed Consent Form
TPL016 Charter for Trial Management group with Independent Chair
TPL017 Charter for Data Monitoring Committee
TPL018 Terms of Reference for Trial Steering Committee
TPL019 Monitoring Plan
TPL021 GP Letter Template
TPL022 Site Personnel Delegation Log Template
TPL023 Material Transfer Agreement
TPL024 Source Data Identification List
TPL025 Screening Recruitment Log Template
TPL026 Study Close Out Checklist
TPL027 Study Close Out Letter
TPL028 Study SOP List Template

 

Guidance Docs (GD)

GD001 Trial Management Considerations
GD002 Initiation Report Form
GD003 Statistical Analysis Plan
GD004 Trial Master File Contents
GD005 Health Records: A Guide for Clinical Research Staff

 

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