Planning and design of your research study
Researchers planning on starting a research project in South London and Maudsley NHS Foundation Trust (SLaM) should consult our guidance documents and contact us as early as possible in the planning stages for advice - we recommend contacting us to make an appointment for a visit or phonecall with a Research Governance Facilitator.
Using IRAS guidance, decide your how your study should be classified.
- Clinical trial of an investigational medicinal product
- Clinical investigation or other study of a medical device
- Combined trial of an investigational medicinal product and an investigational medical device
- Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice
- Basic science study involving procedures with human participants
- Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology
- Study involving qualitative methods only
- Study limited to working with human tissue samples (or other human biological samples) and data (specific project only)
- Study limited to working with data (specific project only)
- Research tissue bank
- Research database
If your work does not fit any of these categories, select the 'Other study'.
Once you have classified your study, you need to use the correct protocol template. All protocols submitted to the REC/HRA should be scientifically sound and you will need to submit evidence of scientific peer review to the ethics committee:
- Peer review by funder (submit confirmation of funder peer review as part of sponsorship request)
- Peer review arranged through the R&D office (guidance)
- Student projects will undergo review by academic supervisors and the relevant academic departmental review process.
If you'll be administering a drug or substance (or intervention deemed high-risk by the sponsor), the protocol must be reviewed by the SLaM/IoPPN Risk Assessment Committee. The Committee meets once per month - download guidance and dates.
Clinical Trial of an Investigational Medicinal Product (CTIMP)
Please download the latest template from the KHP-CTO website along with their SOP on writing a GCP compliant protocol.
Other clinical trial (non-CTIMP)
If you are conducting a non-CTIMP clinical trial (for example a therapy randomised controlled trial) please use the King’s College London CTU clinical trial protocol template.
Basic science study
If you are conducting a basic science study, please use the GCP non-CTIMP protocol template available from the IoPPN/SLaM R&D office.
Qualitative or other research
HRA qualitative research protocol template
For non-clinical research study designs, such as observational studies, the STROBE guidance is a useful resource.
PRISMA statement deals with systematic reviews and meta-analysis.
To include in all study types protocol
The following points should be included in your protocol where applicable:
- The source of study funding on the protocol, and whether anything is being provided (for example if a company is providing the study drug at no cost). For externally funded studies please include details of the funder(s). Where studies have not been awarded external funding please contact the R&D office for an R&D costings form and return this to us with your protocol.
- Where a protocol has not been scientifically reviewed by an external funder, the R&D office will organise an independent peer review. This will be done in parallel with risk assessment review. Please provide the R&D office with the names and contact details of three potential reviewers who have expertise in the area but are independent of the study. We will organise the peer review and forward the comments to you.
- Where participants will be recruited from (for example whether from the NHS, advertisement, existing registries).
- Where the consent and screening visit and subsequent study visits (post-consent) will take place.
- For studies involving a drug, whether consent is taken by a medic, if not, how the consent process will be properly delegated.
- For studies involving a drug, where the drug/placebo is sourced, and which pharmacy is storing and dispensing.
- An outline of risks and burdens (and a description of side effects of the study drug if applicable, including contraindications).
- Safety reporting as per NRES guidelines (or contact the R&D office for a copy of current NRES guidelines). Any safety reporting to NRES must also be copied to the sponsor via the SLaM/IoPPN R&D office.
- If you are taking tissue samples, include details of storage and analysis of all tissue samples (including urine, saliva, hair samples) - where they are stored and analysed and for how long, whether they are stored under an organisational Human Tissue Authority licence, who will have access to the samples in the future (including any other organisations/commercial companies).
- Details of data management – how data will be managed appropriate to the study type, including data handling and coding for computer analysis, monitoring and verification and assuring the quality of the data. Include a description of the statistical methods to be used for the data analysis, reasons for selection of the sample size and power of the study.
- For clinical trials - details of the Data and Ethics Monitoring Committee (DMEC) and Trial Steering Committee (TSC) arrangements, or the reasons if these are not being set up. For all other study types such as basic science please include an explanation of appropriate oversight arrangements.
- It would also be helpful if you could include details of quality assurance of the conduct of the study using Good Clinical Practice standards and SPIRIT statement. Although these standards relate primarily to clinical trials, where appropriate they should be used as a reference for basic science and other study types.
Download protocol templates