Documents

 

We have a selection of template documents to assist you to set up and manage your study as well as application forms and information sheets relating to research activities; if you're unable to find what you are looking for, please contact one of our Clinical Project Managers.

Documents in NUMERICAL order are HERE

To open and download a document form please click on the required link:

A  BCD EFG H I J K LM N OP QR ST U V | W | X | Y | Z

 

A.
Adverse Event Reporting Investigator Responsibilities FRM004
Adverse Event Reporting (Not SAE, SAR, SUSAR) FRM005
Adverse Events Reporting (SAE, SAR, SUSAR) FRM007 
Adverse Events Reporting Sponsor Responsibilities FRM003
Archive Retrieval Form FRM059
Audit Certificate FRM061
Audit Notification Letter FRM062
Audit Report FRM025
B.
C.
Certificate of Destruction FRM060
Charter for Data Monitoring Committee TPL017
Charter for Trial Management Group with Independent Chair TPL016
Codebreak (Unblinding) Randomised Clinical Trial Request (same form as unblinding (codebreak randomised clinical trial request) FRM029
Codebreak Test procedure FRM030
Competency Booklet and Assessment Forms
Curriculum Vitae (CV) Template and instructions
Curriculum Vitae (CV) Template
D.
Data Amendment FRM002
Data Query FRM026
Database Lock and Close Down FRM017
Database Training Data Entry Training FRM015
Database Testing/Validation and Acceptance FRM018
Database Unlock Request FRM019
Database Using Formic Guidance FRM020
Database Validation Specifications FRM016
Data Monitoring Committee Charter TPL017
Delegation Log (Site Personel)
Delegation Log (Project Management -CPMs) FRM042
Development Safety Update Report FRM045
Drug Accountability Log FRM031
Drug (CTIMP) under Quarantine FRM035
Drug (CTIMP) Quarantine File Log (same form as IMP quarantine file log) FRM 036
Drug Recall Handling FRM033

E.

Emergency Trolley Weekly Checklist FRM014
F.
File Note TPL007
G.
GP Letter
G Power Manual (Statistics)
H.
Health Record Completetion: A Guide for Clinical Research Staff
HRA Statement of Activities
HRA Schedule of Events
I.
IMP Quarantine File Log (same form as drug (CTIMP) quarantine FRM036
IMP Under Quarantine (same form as drug CTIMP under quarantine) FRM035
Induction Checklist
Induction Handbook (v 4.0 May 2016): New Staff
Initiation Report Form GD002
Investigator File Contents Checklist FRM021
J.
K.
L.
M.
Material Transfer Agreement (MTA) Form
Memorandum of Understanding (Papworth sponsored studies) FRM028
Memorandum of Understanding (Non-Papworth sponsored studies) FRM040
Monitoring Report (monitoring of site file) TPL010
Monitoring Report (monitoring source data & case report forms) FRM027
 
N.
 
O.
Office Etiquette
OpenClinica Design Changes FRM037
OpenClinica Data Amendments FRM039
P.
Pathology Registration Form FRM064
Patient Information Sheet - Tissue Bank
Patient Information and Consent Form
Patient's Research Guide

Pharmacy Directorate Approval FRM063

Pharmacy Monitoring FRM044

Protocol Non-Compliance FRM038
Protocol Template (CTIMP)

Protocol Template Non CTIMP

Protocol Template Research (Trial Management)
Protocol: Service Evaluation
Q.
R.
Radiology Approval Form FRM065
Regulatory Green Light Checklist for NON-Papworth Sponsored Trials
Research Skills Course Application Form
Research Guide for Patients
Research Passport Application Form
Research Passport Application form (Instructions for completing)
Resuscitation Trolley Checklist FRM014
Risk Assessment of Papworth Sponsored CTIMP Products FRM024
Risk Assessment Tool FRM013
S.
 SAE, SAR, SUSAR Reporting FRM007
Service Evaluation Protocol
Site Initiation
SMPC Review Checklist FRM041
SOPs
Sponsorship Responsibilities Agreement (Papworth sponsored studies) FRM028
Sponsorship Resbonsibilities Agreement (Non-Papworth sponsored studies) FRM040
Statistical Analysis Plan GD003
Statistics: g-Power Manual
Subject Specific Drug Accountability Log Template FRM032 
Site Visit Log FRM054
T.
Terms of Reference for Trial Steering Committee TPL018
Tissue Bank Application Form
Tissue Bank Patient Information Sheet
Trial Management Considerations GD001
Trial Master File Contents (Inlcluding key docs) GD004
Trial Master File Template
Trial Monitoring Group Charter TPL016
Trust Approval Green Light Checklist (Papworth Sponsored Studies) FRM023
U.
Unblinding (Codebreak) Randomised Clinical Trial Request Form (same form as codebreak (unblinding) randomised clinical trial request form) FRM029
V.
Version Control of Trust Approved Documents FRM012
W.
X.
Y.
Z.
Please click here for SOPs
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