Info: Zenodo’s user support line is staffed on regular business days between Dec 23 and Jan 5. Response times may be slightly longer than normal.

Published January 2, 2024 | Version V1
Proposal Open

Protocol Deviation Framework

Creators

  • 1. ROR icon University College London
  • 2. ROR icon University of Bristol
  • 3. The University of Sheffield
  • 4. ROR icon University of Nottingham

Contributors

  • 1. ROR icon University College London
  • 2. ROR icon University of Bristol
  • 3. The University of Sheffield
  • 4. ROR icon University of Nottingham

Description

Backgrouond: Looking for, processing and acting on protocol deviations are an important part of ensuring good trial conduct.There are definitions of protocol deviations in the ICH Good Clinical Practice series but there is little practical advice on the process for protocol deviations. 

Methods and Results: Using semi-structured discussions between 5 CTUs in the UK and a CRO in Kenya, we developed a protocol deviation framework 

Summary: We hope this framwork will improve protocol deviation process and efficiency. It will also serve as a launchpad for further research on the collection, processing and relevant action for protocol deviations.

Files

Files (432.6 kB)

Name Size Download all
md5:2c7ffbdd20f492b7b57dd106c9b77c5d
432.6 kB Download

Additional details

Funding

Method-Conduct MC_UU_00004/08
MRC Clinical Trials Unit at UCL

Dates

Issued
2024-01-02
Protocol Deviation Framework