Good Clinical Practice (GCP) requirements for ANODE V6.0 17/01/17

GCP requirements for ANODE For all clinicians taking informed consent from women:- Full GCP training – ANODE presentation ‘A’ (this presentation) and entered onto the Training and Delegation Logs (signed off by PI prior to any ANODE tasks carried out) For all clinicians Prescribing:- ANODE presentation ‘A’ and entered onto the Training and Delegation Logs (signed off by PI prior to any ANODE tasks carried out) V6.0 17/01/17

Other staff involved in ANODE Randomising, mixing and administering:- ANODE Presentation ‘B’ Entered onto the Training and Delegation Logs (signed off by PI prior to any ANODE related tasks carried out) Checking the IMP:- No formal ANODE training required Read and sign off ‘Information sheet for all staff checking the ANODE IMP’ laminated sheet kept with IMP box to confirm understanding of blinding requirements V6.0 17/01/17

GCP and Consent Lets talk about ANODE ANODE V6.0 17/01/17

Your role in ensuring Good Clinical Practice (GCP) Your role is to:- Identify and adhere to the eligibility criteria Understand the process for receiving informed consent Understand your role in data collection Understand your role in monitoring safety of study participants And by doing so you are ensuring:- The safety and integrity of research participants The quality of the data Please ensure that you conduct this trial in compliance with the protocol which has been approved by the Research Ethics Committee and your R & D Department Please refer to the 14 Principles of GCP – contained in your training pack for further information V6.0 17/01/17