Coordinate study work-up

In the study work-up, preparations are made to ensure that all the relevant documents and internal approvals are in place before applications to ethical and regulatory bodies can be made.

For College-sponsored studies, the CI/study team is responsible for coordinating this work; for commercially-sponsored studies, the JRO's Trust team will manage this.

You will need a protocol, participant information sheets, consent forms, a letter from your study sponsor (acknowledging that they are taking on sponsorship responsibility) and other study documentation in order to submit to the Research Ethics Committee, to NHS Research and Development and to other regulatory bodies.

Please consult the checklists, which cover all the potential documents and approvals needed to conduct a study, including:

• study and funding: protocol, funding proposal and agreement, where applicable
• sponsorship and agreements: letter confirming sponsorship, agreement of roles and responsibilities (eg between the sponsor and participating sites), service level agreements, material transfer agreement if applicable
• consent materials: information sheets and consent forms
• approvals: submission to and confirmation of acceptance by regulatory authorities (eg REC, NIGB), where applicable 
• amendments: notification of substantial amendments, evidence of approvals for all substantial amendments, if applicable
• reporting: serious adverse events (SAEs), annual reports submitted to ethics committee, if applicable