Protocol guidance and template for use in a Clinical Trial of an Investigational Medicinal Product (CTIMP) – for consultation in use (Closed)

Background

The HRA has become aware that the quality and content of protocols for CTIMPs received by the HRA and other reviewers is highly variable. This is particularly, though not entirely, an issue for non-commercial CTIMPs. Strong feedback to the HRA highlighted considerable variability of content and sometimes poor quality of protocols was causing delays to reviews. In response to this the HRA facilitated work to develop guidance and a template to assist organisations and individuals to improve the consistency and quality of their CTIMP protocols.

A protocol which contains all the elements that review bodies consider is less likely to be delayed during the review process because there will be less likelihood that the review body will require clarification from the applicant.

A multidisciplinary group of individuals from research active organisations and regulators provided expertise to the project which has produced detailed guidance and a template that is in-line with international SPIRIT guidelines. A full list of collaborating organisations can found in Appendix 1.

The guidance and template are published for use and comment.

(The template has been updated to version 1.1 to correct section 7.12 as of January 2015)

Is it mandatory to use this guidance and template?

No. The use of this collated consensus guidance and template is not mandatory. The guidance and template are published as standards to encourage and enable responsible research. The documents will:

  1. Support researchers developing protocols where the sponsor does not already use a template
  2. Support sponsors wishing to develop template protocols in line with national guidance
  3. Support sponsors to review their existing protocol template to ensure that it is in line with national guidance.

Can sponsors continue to use their own protocol templates?

Yes. The HRA acknowledge that institutions have specific needs, including specialised additional material, and may have their own templates. The HRA ask that sponsors advise those preparing protocols how their template has regard for the HRA guidance and template. In addition, the HRA recommends that each protocol states clearly how it meets HRA guidance:

  • The protocol has regard for the HRA guidance and order of content
  • The protocol has regard for the HRA guidance
  • The protocol does not have regard to the HRA guidance and order of content

What are the benefits of using the guidance and template?

By clearly defining the expected components of a protocol, the guidance and template help researchers to be sure that they have covered all the elements required by  sponsors, Research Ethics Committees, the Medicines Healthcare Regulatory Authority (MHRA), and NHS sites. In the future this will also apply to applications for HRA Approval. Protocols which have regard for the guidance and template are less likely to raise queries that can cause delays.

Who can use the template?
The template can be used by all individuals and sponsoring organisations involved in authoring any phase of CTIMP.  It is envisaged that this template will be used primarily by non-commercial sponsors and smaller commercial sponsors in the UK. It is acknowledged that many commercial sponsors already use high quality protocol templates but we would welcome feedback from such sponsors.

Where will the guidance and template be available for use and comment?

The guidance and template can found here.

In order to inform future guidance and templates user feedback will be requested from all stakeholders whether authors, reviewers or users for completed protocols.

How do I provide feedback?

We are requesting comment until the end of June 2015, when the feedback will be analysed and the guidance and template, revised as appropriate.

Feedback can be emailed to HRA.Protocols@nhs.net.  Please contact us via this email address if you would prefer to provide feedback in person or by telephone, and we can arrange a time to speak with you.

Appendix 1 – Collaborators:

A multidisciplinary group of individuals from the following research active organisations provided expertise to the project:

  • EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network Manchester Academic Health Science Centre
  • Cancer Research UK Clinical Trials Unit (CRCTU)
  • University College London Partners (UCLP)
  • King’s Health Partners (KHP)
  • Imperial Health Partners (IHP)
  • Liverpool Health Partners
  • Oxford Academic Health Science Centre
  • University of Aston
  • Cambridge University Health Partners
  • Leeds Partnership
  • Leeds Clinical Trials Unit
  • The Royal Brompton
  • University of Wolverhampton
  • The Institute of Cancer Research Clinical trials and Statistics Unit
  • Bristol Health Partners
  • King’s Clinical Trials Unit
  • University of Cumbria
  • The Royal Marsden
  • Northumberland, Tyne and Wear CRN
  • Bradford Institute for Health Research
  • North and East Yorkshire and Northern Lincolnshire CRN
  • North Yorkshire and Humber Commissioning Support Unit
  • Cambridgeshire and Peterborough CCG
  • Primary Care West Yorkshire
  • Cambridge Clinical Trials Unit
  • Medicines and Healthcare products Regulatory Authority
  • Association of the British Pharmaceutical Industry