About the Generic Document Review Committee (GDRC) and this guidance
The GDRC reviews generic recruitment materials for Phase 1 and clinical trials more generally. Clinical trials units and contract research organisations (CROs) often advertise and screen for potential participants in general terms, before inviting them to take part in a specific clinical trial that requires a favourable ethical opinion from a review by a Research Ethics Committee (REC). The GDRC reviews these generic materials centrally, for consistency. A key role of the GDRC is to ensure that they are clear, non-coercive and ethical.
This guidance sets out the essential requirements for all submissions, what to include and advice on writing your materials. All of which should be met before materials are sent to the GDRC. Submissions that do not follow this guidance will be returned and the applicant asked to review the advice and resubmit.
Scope and legal position
Submissions should be generic material and not specific to a particular clinical trial that requires a favourable ethical opinion from a review by a REC. Documents designed for use in a specific clinical trial are required to be submitted to the REC undertaking the ethics review of that trial, not to the GDRC.
Under regulation 12 of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (the clinical trials regulations), a clinical trial must not start without a favourable ethics committee opinion and authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA), and no advertisement may be issued to recruit participants to a trial until the ethics committee has given a favourable opinion. However, activities undertaken before a clinical trial starts, such as generic advertising and screening that is not linked to a particular trial, are not part of ‘conducting a clinical trial’ as defined in regulation 2(1), which excludes preparations made before a trial starts.
There is therefore no legal requirement for generic materials to be reviewed by the GDRC but as a matter of best practice, applicants are expected to submit any proposed generic materials to the GDRC for review before they are used. Materials that have received a favourable GDRC opinion will be retained and accessible to the reviewing committee should they wish to view them in the context of a specific trial that would require a favourable ethical opinion. Please note that a REC can request changes to documents that have received a favourable GDRC opinion when reviewing them as part of a full application for a specific clinical trial.
Further information on the remit of the GDRC is available on our Phase 1 clinical trials webpage.
Essential requirements for all submissions
To maintain a level of consistency for all submissions and to support clear audit processes, the following information has been developed to support all applicants with their submissions to the GDRC. Following this guidance will support an applicant's submission through the GDRC review process.
Controlled documents
The GDRC’s opinion attaches to specific, identifiable documents that are submitted for review. Each submission is triaged and allocated a specific GDRC reference number, and this is shared with the applicant by email. Our review record (email) and the opinion we issue state precisely what was reviewed, by document title, version number and date, so that material in circulation can be matched unambiguously to the material that received a favourable opinion.
All wording for review must therefore be in a controlled document. Wording given only in the body of an email, text message or other electronic message cannot be identified in that way. Message text is also unstable: it is reformatted by different programs and devices, truncated in reply chains and can be edited on forwarding without any visible trace, so neither the GDRC, the sponsor nor the site could later establish which wording was reviewed. Email remains the only way to send submissions to the GDRC and to receive its opinion.
Document identification
Each document must show, normally in the footer, the GDRC reference (where one has been allocated), your organisation’s own document reference, a document title, a version number and a date. The file name should match the footer and the author and review status should be apparent.
Version control
Any change to the wording of a previously approved document requires a new version number and date, to show what has changed, when and under which GDRC opinion. The first version submitted is the baseline against which later changes are controlled. Without it, there is no way to show which version was in use during any given recruitment period.
Format
Submit documents in Microsoft Word so that changes can be tracked. Where the final design is produced in other software (for example, a largely image-based advertisement), a PDF may be acceptable if it has been through Optical Character Recognition (OCR), so that text can be highlighted and amendments suggested. Text-heavy PDF documents (such as some posters) should always be accompanied by a Word document containing the text.
Quality
Materials should be of high quality and fully legible, as potential participants will see them. Documents must be thoroughly proofread before submission. Submissions containing numerous spelling or grammatical errors will be returned for correction, which will delay the review.
What to include in your submission
Before submitting, check any previous GDRC review of similar materials and address the points raised, so that the same issues are not raised again.
Each submission should include a supporting document (information given only in an email or other message is not sufficient) that:
- lists each document for review by title, version number and date
- states whether this is a new submission or an amendment to documents that have previously received a favourable GDRC opinion – for an amendment, attach a copy of the previous GDRC opinion email, a tracked changes version and a clean version of each amended document, so that there is a clear audit trail
- confirms that the materials are generic and not designed for use in a specific clinical trial that requires a REC favourable ethical opinion
- explains the content of the materials and how and where they will be used (for example, on posters, websites or social media), with any other supporting information that will support the GDRC review
Please also include:
- the wording of any email or other communication (for example, SMS text messages, WhatsApp or other messaging app messages, social media posts or direct messages, letters, newsletters, telephone or voicemail scripts, screening invitations and appointment reminders) that will be sent or read out to potential participants, within a controlled document (see the 'format' section of this guidance)
- any content the materials link to (for example, a website, online registration form or QR code destination), as potential participants will see it, together with any associated privacy notice
- for multimedia files (for example, videos), a storyboard in a Word document that clearly sets out the wording and images to be used. Producing a video before review can be expensive and time-consuming if changes are requested. Once the storyboard has received a favourable opinion, produce the video using the exact wording reviewed and submit the finished video for completeness of our records
Submissions should be sent to GDRC@hra.nhs.uk.
Writing your materials
The HRA Participant Information Quality Standards set out expectations for information given to people who are invited to take part in research. Although they focus on specific clinical trials, many of their principles apply equally to generic materials:
Language and terminology
All submissions to the GDRC must fully consider the 'audience' to which the materials are directed at. The language and terminology used must be in a lay language that is clear and easy to understand avoiding acronyms and complex medical terminology. Examples include:
- use ‘clinical trial(s)’ rather than ‘research’, ‘research trial’ or ‘study’ where what is being advertised meets the definition of a clinical trial of an investigational medicinal product (investigating how safe and/or how effective a potential medicine might be when used to treat, prevent or diagnose human illness). This makes the legal status clear
- refer to ‘participants’, not ‘patients’. The clinical trials regulations use the term ‘participant’ (previously ‘subject’) and ‘patient’ may suggest that taking part is part of clinical care
- refer to ‘investigational medicine’, not ‘drugs’ and to ‘investigating potential new treatments’ where applicable
- use UK rather than US terminology – for example, ‘blood sample collection’ rather than ‘blood draw’ and the use of 'examination', rather 'exam'
Who you are recruiting
All submissions to the GDRC must fully consider who it is they are trying to recruit and therefore the content must also accurately reflect the requirements of the target audience. You must:
- be clear about who you are seeking to recruit (for example, age, health status or medical condition), so that people can rule themselves out before giving their time or personal data
- make clear that taking part is voluntary and that registering an interest or attending screening is not the same as agreeing to take part in a clinical trial
Payments and benefits
Payments and benefits for participation in a clinical trial require careful consideration to avoid any coercion. You must:
- be clear about participant payments and any reimbursement of expenses but do not make payment the headline or the most prominent feature of the material. The only amount the GDRC can give a favourable opinion on is ‘from £200 per day’ if that is a true reflection of what will be paid or, where the minimum paid is lower, ‘from £[lower amount] per day’. Otherwise, the GDRC can review wording that uses a placeholder (for example, ‘insert payment’) but not the actual amount
- not highlight benefits where there may be none. Clinical trials of investigational medicines may offer no benefit, so avoid phrases such as ‘potential relief from your condition’. Remember there is no direct benefit for healthy volunteers
Personal data and access
All UK data protection policies and procedures must be fully considered when developing your materials. You must:
- only ask for the personal data you need and explain why you need it. This reflects the data minimisation principle under UK data protection law
- always give another option to get in touch when using a QR code or web link (for example, a telephone number or email address)
After the initial GDRC review
If the GDRC review requests changes, please resubmit 2 versions of each amended document: a tracked changes version showing how each point raised by the GDRC has been addressed and a clean version (all changes accepted). Both versions must carry a new version number and date.
Where the software used to produce the materials cannot track changes, it remains the applicant’s responsibility to show as clearly as possible what has changed and how each point has been addressed. As a minimum, a PDF must have been through OCR (see the 'format' section of this guidance).