The ACRIN Principal Investigator (PI) Manual provides researchers—both the trial PI who leads the research effort and the site PI who implements the research at an ACRIN-affiliated site—with a generic overview of trial responsibilities and the support provided by ACRIN.
More general information about PI responsibilities can be found in ACRIN's Principal Investigator's Manual [PDF] and the Investigator's Handbook developed by the Cancer Therapy Evaluation Program of the National Cancer Institute (http://ctep.cancer.gov/handbook).
Active participation of the ACRIN trial PI during all stages of protocol development and activation is crucial to the success of the trial. The following list provides a sample of the trial PI responsibilities at each stage of the trial.
During Protocol Development:
- Leads and assists in the development of protocol, protocol-specific application, and data collection forms
- Interacts with the outcomes experts, statisticians, and other methodologists as required for protocol development and analysis
- Interacts with key experts related to establishment of standardization of technical parameters of protocol images
While Protocol Is Active:
- In collaboration with the study statistician, leads the work on monitoring study progress, including accrual, data collection, and data monitoring
- Answers protocol-specific eligibility and protocol procedure questions
- Assists in the establishment of target accrual goals for participating sites and works with ACRIN recruitment specialist to develop specific patient recruitment strategies
Throughout Development and Activation:
- In collaboration with personnel at ACRIN headquarters, develops the agenda and leads the discussions on protocol-specific conference calls
- Presents the status of the trial at semiannual meetings when requested and leads meeting sessions devoted to protocol development, implementation, and ongoing needs
- Follows up with PIs at sites not meeting accrual goals to assess accrual barriers and develops and monitors a remedial plan to improve accrual
After Study Closes to Accrual:
- Continues to work with the protocol team, other investigators, and participating sites to follow up participants and ensure adequate data collection
- Works with protocol team on implementing subanalyses and the initiation of reader studies
- Organizes and leads the work on preparation of manuscripts for publication