Compliance with the regulations | Trial templates
Useful templates have been provided for use in your investigator/ trial file. These are part of the list of essential documents that are required for trials of medical products but we would like to encourage researchers to use them for any type of research project. You can also adapt them as you wish.
Download Study team guide to CRF design.
Download Lab file contents page.
Download Sample collection and shipping instructions.
Download Essential Document Checklist (Appendix E of SOP 28).
Download Acknowledgement of receipt of protocol.
Download Protocol front sheet.
Download V4 Delegation Log.
Download Screening log.
Download Enrolment log.
Download Freezer temperature log.
Download Sample receipt log.
Download Site visit monitoring log.
Download Staff training log.
Download Adverse event list template.
Download Annual Safety Report Template V4.
Download Annual Safety Report template - non started trials V1.
Download SAE Reporting Form V4.