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  • Research and Development Pr...
  • Professional Information
  • Information and guidance
  • Information sheets

Information sheets

Research and Innovation has produced a number of guidance/information sheets to help researchers in applying for approval(s) and in the conduct of their study.

Sponsorship

How to gain WAHT sponsorship

Approvals

Applications for local Research & Development approval

Applications for study wide approval

Protocols: guidance on writing protocols

Clinical trials protocols

Observational studies

Qualitative studies

Non-IMP randomised trial

Protocols: standard wording to include in protocols

For IMP studies for which WAHT is sponsor (Guidance sheet 3a)

Non-IMP studies for which WAHT is sponsor (Guidance sheet 3b)

Once your study has been approved

Points to remember - IMP studies

Points to remember - Non-IMP studies

Guidance on Investigator Site File (ISF) - IMP studies

Guidance on Investigator Site File (ISF) - Non-IMP studies

ISF Template - IMP studies

ISF Template - Non IMP studies

Responsibilities of a CTA holder

Monitoring research studies

Amendments

Amending study specific documentation

Converting from a single site to a multi site study

Reporting

Annual and end of study reports

Safety

Investigator responsibilities

Research Management Office responsibilities

Study closure

Early closure of a study

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