TRIAL PRINCIPAL INVESTIGATOR RESPONSIBILITIES

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
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