Guide and Flowcharts

1. Scientific Review
2. Design a study protocol
3. Funding Collaboration
4. Classified as research

1. Documents
2. IRAS Authorisation
3. Sponsorship Application
4. Participants Documentation
5. Information Sheets
6. Consent form
7. Recruitment Materials 
8. Debriefing form/letter
9. CV
10. GCP Certificates
11. Peer/ Scientific Review
12. Schedule of Events
13. Statement of Activities
14. Contracts
15. Risk Assessment 
16. HTA Assessment 

1. Amendments
2. IRAS Authorisation
3. Sponsorship in Principle 
4. Book the study with REC and HRA
5. Book the study with MHRA

1. Review and Accept Application
2. Attend or dial in
3. Feedback 
4. Amendments
5. Favourable Opinion Letter

1. Amendments
2. Feedback
3. Approval
4. Liaising with NHS R&D or local organisations

1. Review of all documentation
2. Statement of Activities 
3. Research Passports
4. Fees and Contract Agreement 

1. Sponsor Checks
2. Project File signed and dated
3. Monitoring and QA Schedules Instigated 

Commence Recruitment 

Download the SU guidance for IRAS form completion here.

For more information, visit our Documents and Templates page.

• The University’s Public Liability cover applies to most non-interventional research (e.g. purely qualitative or questionnaire-based studies);
• The Clinical Trial cover automatically applies to low-risk studies which meet the following criteria:

1. Questionnaires, interviews, psychological activity including CBT;
2. Venepuncture (withdrawal of blood);
3. Muscle biopsy;
4. Measurements or monitoring of physiological processes including scanning;
5. Collections of body secretions by non-invasive methods;
6. Intake of foods or variation of diet (other than administration of drugs &/or nutrients).

• all CTIMPs and all higher-risk interventional studies will need to be referred to Swansea University Insurance UMAL in accordance with the criteria in the attached flowchart

For more information   Insurance Clinical Trials Flowchart