PRIOR to your CTIMP training, you will need to download the following documents onto your laptop or tablet, because WiFi may not be available in the training room.
Alternatively, you can print off hard copies and bring them with you. We will not be providing materials on the day. The presentation for delegates is a large document, so we recommend that you print off six slides per page and print on both sides of the paper.
- Presentation slides for CTIMP GCP training
- GCP training glossary
- The 14 principles of GCP
- Serious Adverse Event report form
- Completed patient information sheet
- Consent form checklist
The following materials are working tools. You do NOT need to download or print off these documents for the training session. However they will be discussed so, following requests from previous delegates, we have collected them together here in one easy to find section.
- TMF ISF Contents CTIMP can be found in SOP S-1015 UHL Appendix 1 TMF ISF Contents CTIMP
- Subject Screening log can be found in SOP S-1011 Appendix 4 Subject Screening Log
- Subject Enrolment log can be found in SOP S-1011 Appendix 5 Subject Enrolment Log
- Blank DoA Signature log can be found in SOP S-1006 Appendix 1 Blank DoA Signature Log
- SAE Reporting form can be found in SOP S-1009 UHL SAE Form A Completion Guidance Document CTIMP
- Pregnancy reporting form can be found in SOP S-1009 Appendix 1 FINAL Pregnancy Reporting Form
- Template file note can be found in SOP S-1013 Appendix 2 Template file note