Clinical Research Adoptions Committee (CRAC)
The Clinical Research Adoptions Committee (CRAC) is an internal peer review committee that meets to review and endorse any clinical research projects taking place within Great Ormond Street Hospital (GOSH) that are not externally funded (‘own-account projects’) or funded by an external body where adequate peer review of the project proposal has not taken place. The committee aims to ensure the standard and quality of clinical research within GOSH.
This committee, chaired by Dr Owen Arthurs, sits monthly (except August) to review protocols. It is composed of a combination of senior clinicians actively engaged in clinical research, psychologists, allied health professionals, academics and a statistician. CRAC can suggest the use of extra GOSH resources and will provide advice on statistics, research methods and research ethics.
We strongly recommend that you submit your application to CRAC prior to seeking ethics or regulatory approval.
Do I need CRAC review?
All research projects at GOSH (clinical) that are unfunded (or not sufficiently peer reviewed) need CRAC review. If your answer is "Yes" to the three questions below, please follow the process for submitting an application to CRAC.
Is your project research?
Research is defined by the Research Governance Framework as an “attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods.”
To determine if your project is classed as research and whether it may need ethics review, please use HRA decision tools:
Other activities such as clinical audit, local developments of existing research, the introduction of clinical innovations, service evaluations, patient and staff surveys and quality assurance programmes may not qualify as research even though they may use similar methods. CRAC does not need to consider service evaluations or clinical audits. At GOSH, these are reviewed by relevant teams and should instead be registered there.
If you are unsure whether your project requires CRAC approval, please email CRAC.Admin@gosh.nhs.uk
Is your project clinical?
It involves any GOSH resources, GOSH staff or GOSH patients (including patient samples or data).
Is your project "own-account"?
It is unfunded and you have not secured funding to cover the cost of GOSH/ICH resources (staff time, service support costs, consumables) associated with the project. Or your project has not gone through an appropriate peer review process.
Submitting an application to CRAC
To apply for review by CRAC you need to complete and submit the following documents (please refer to side-bar to download these documents and to check submission deadlines):
- CRAC Application form
- A study protocol (templates available on e.g. HRA website)
- Other documents relevant to your study, such as: Questionnaires, Patient Information sheets, Consent forms.
Please nominate two peer reviewers on your application form for all new studies. Failure to nominate peer reviewers will result in your application being returned.
If your study is a multi-centre study and/or has already been peer reviewed then you do not have to nominate two peer reviewers; instead, you need to provide evidence of the peer review.
When completed, the application form must be sent by email to CRAC.Admin@gosh.nhs.uk
There is the opportunity to attend the CRAC meeting to discuss your application in person, the committee secretary will organise this once your CRAC application has been registered.
Once your application has been reviewed, the committee secretary will contact you to inform you of the outcome.