1. The trial team, Biostatistical and Data Management Center, and ACRIN Headquarters collaboratively develop a timeline for future activities and assign roles and responsibilities to members of the protocol team.
2. The trial team develops the protocol, including recommendations made by CTEP, and submits the protocol for CTEP approval.
The trial team should include the PI; additional imaging and nonimaging specialists who are experts in the disease site and technologies represented in the trial; statisticians; other methodologists; headquarters support staff (project management, regulatory, data management, and audit personnel); a patient advocate; and such other experts as are necessary to develop a rigorous protocol.
The team, led by the PI, begins to develop the protocol using the ACRIN Protocol Development template and accompanying guidelines. Once a draft of the protocol is completed, the protocol team reviews it fully. Revisions are incorporated into the protocol and it is sent to CTEP for review and comments. CTEP may either approve the protocol outright or respond with comments. If comments are provided, the team revises the protocol accordingly and resubmits the draft until it is approved by CTEP. The protocol also must be reviewed and approved by the ACR Institutional Review Board (IRB) which can happen simultaneously with CTEP submission.
Protocol Development Template [DOC]
3. CTEP approves the protocol and the trial opens.
Once the protocol is approved, participating sites submit the protocol to their IRB for approval and work to meet all other participation criteria. In addition, ACRIN provides site research personnel with training related to carrying out the protocol prior to their site’s activation. Once several sites have demonstrated their readiness to begin participant enrollment, the protocol is activated. Sites join the active study when all participation criteria are met.