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2003 Step 1: Developing a Cancer Prevention Clinical Trial

Multicenter Guidelines

A Lead Organization conducting multi-institutional studies in the consortium has specific responsibilities in order to comply with the DCP Multicenter Guidelines. The Lead Organization is responsible for the following at all Participating Organizations as well as the Lead Organization:

  • Acting as the single liaison with the DCP Protocol Information Office (PIO);
  • Coordinating, developing, submitting, and receiving the approval of the protocol as well as its subsequent amendments;
  • Rewriting or modifying the protocol;
  • Assuring that all Participating Organizations are using the correct version of the protocol;
  • Overseeing the conduct of the study at all Participating Organizations and for monitoring its progress;
  • Registering, tracking, and reporting participant accrual and adherence to defined accrual goals;
  • Ongoing assessment of participant eligibility and evaluation of response;
  • All reporting requirements to DCP;
  • Medically reviewing and assessing participant data;
  • Reviewing all study adverse events to assure participant safety;
  • Maintaining documentation of adverse events reports on all study participants;
  • Reporting all adverse events (AE) and serious adverse events (SAE) to DCP;
  • Developing methods to ensure rapid communication of information within the consortium and to DCP (e.g., adverse events, accrual and response data);
  • Providing study-related information and education to all Participating Organizations;
  • Establishing data management support capabilities that ensure appropriate reporting of clinical trials data to DCP;
  • Ensuring that the proper training is completed before the implementation of a study (e.g., remote data capture, human subjects protection);
  • Evaluating and considering the outcome measures in the interim as being consistent with study participant safety and good clinical practice (GCP);
  • Ensuring that each Participating Organization has an appropriate assurance on file with Office of Human Research Protection (OHRP);
  • Submitting an OHRP Form 310 to DCP prior to protocol activation at a Participating Organization;
  • Collecting all regulatory documents and/or administrative documents for the study (including Participating Organizations) and submitting them to DCP;
  • Submitting a Quality Assurance Plan (QAP) for Remote Data Capture (RDC);
  • Preparing and submitting all data for review to DCP;
  • Reviewing and submitting all study data for analysis;
  • Submitting a Multi-Institutional Monitoring Plan (MIMP) to DCP 30 days following the contract award;
  • Submitting a Data and Safety Monitoring Plan (DSM) to DCP for each protocol;
  • Monitoring all aspects of the study at the Participating Organizations; and
  • Providing study data (e.g., source documents, case report forms) from participating organizations for an independent audit (see Step 3, SOP #3 on the 2003 DCP Consortia for Early Phase Prevention Trials page).

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