2003 DCP Consortia for Early Phase Prevention Trials

These documents are for the use of the DCP Consortia staff conducting cancer chemoprevention studies under contract with the NCI/DCP.

Consortia Source Documentation Guide

Download PDF (198 KB)

Develop/Step 1

NCI funding assistance for a cancer prevention clinical trial requires a formal application from the investigators followed by several levels of concept evaluation and peer review. Establishing these underpinnings means delving into:

Investigational Agent Distribution and Management

Conduct/Step2

Standard Operating Procedures

The Standard Operating Procedures (SOPs) listed below are written to help study staff in the conducting of a Cancer Prevention Clinical Trial.

SOP #1 Communication with Participating Organizations: Forms and Procedures

  • Responsibilities (SOP) (DOC, 49KB)
    Lists the Consortia responsibilities during communication with Participating Organizations.
  • Checklists/Documents
    • None for this SOP.

SOP #2 Collection and Submission of Regulatory Documents

SOP #3 Review and Tracking of Participant Recruitment, Retention and Adherence

  • Responsibilities (SOP) (DOC, 55KB)
    Lists the Consortia responsibilities during review and tracking of recruitment, retention and adherence plans at participating organizations.
  • Checklists/Documents

SOP #4 Recording and Reporting Protocol Deviations

SOP #5 Reporting and Tracking Serious Adverse Events

  • Responsibilities (SOP) (DOC, 69KB)
    Lists the Consortia responsibilities during reporting and tracking of SAEs.
  • Checklists/Documents
    • DCP Serious Adverse Event Form
    • Serious Adverse Event Form Instructions for Completion
    • Summary of Reporting Responsibility for Serious Adverse Events (SAEs)

SOP #6 Using Updated Versions of Paper and Electronic Case Report Forms

SOP # 7 Reviewing and Amending the Division of Cancer Prevention Consortia Standard Operating Procedures

  • Responsibilities (SOP) (DOC, 55KB)
    Lists the Consortia responsibilities during review and amendment of DCP SOPs.
  • Checklists/Documents
    • None for this SOP.

Quarterly and Annual Progress Report Requirements

The Quarterly and Annual Progress Report Requirements are written to help study staff identify requirements for DCP Progress Reports.

The purpose of the Quarterly and Annual Reports is to provide a description of the activities during the reporting period, to discuss any problems encountered and to detail the activities planned for the next reporting period.

The Quarterly Progress Report shall be submitted in a format specified by DCP and will include an expenditure summary for the consortium including expenditures specific to each clinical trial.

All Quarterly and Annual Progress Reports are submitted to the NCI Contracting Officer, DCP Project Officer, and Head, DCP Protocol Information Office. The first reporting period consists of the first full three calendar months of performance plus any fraction of the initial month. After that, the reporting period is every quarter. At the end of each contract year, an annual (cumulative) report is submitted in lieu of the quarterly report.

Monitor/Step 3

Standard Operating Procedures

The Standard Operating Procedures (SOPs) listed below are written to help study staff in the monitoring of a Cancer Prevention Clinical Trial.

SOP #1 Identifying Staff to Conduct On-Site Monitoring Visits for the DCP Prevention Consortia

  • Responsibilities (SOP), (DOC, 69KB)
    Lists the Consortia responsibilities during the identification of staff to conduct on-site monitoring visits.
  • Checklists/Documents

SOP #2 Conducting Study Initiation Visits

  • Responsibilities (SOP) (DOC, 71KB)
    Lists the Consortia responsibilities during the conducting of study initiation visits.
  • Checklists/Documents
    • Attendance Sheet (DOC, 36KB)
      Use as a tool to document attendance of each participant, either in-person or remote, in the study initiation visit.
    • Site Monitoring Visit Log (DOC, 46KB)
      Use to document monitor and site staff attendance during the site visit.
    • Clinical Study Initiation Visit Report (DOC, 169KB)
      Use to document findings of study initiation visits. It can also be used as a preparation worksheet for initiation visit tasks.
    • Site Visit Report Timeline (DOC, 62KB)
      Use to identify standard timeframes for distribution of site visit reports (initiation, annual/interim or close-out).

SOP #3 Conducting Annual/Interim Monitoring Visits at Participating Organizations

SOP #4 Oversight of Participating Organizations

  • Responsibilities (SOP) (DOC, 62KB)
    Lists the Consortia responsibilities during the conducting of off-site monitoring.
  • Checklists/Documents
    • None for this SOP.

SOP #5 Preparing for Annual/Interim Monitoring Visits and Quality Assurance Audit Visits at Consortium Lead Organizations

  • Responsibilities (SOP) (DOC, 69KB)
    Lists the Consortia responsibilities during annual/interim monitoring visits and QA audit visits at CLOs.
  • Checklists/Documents
    • Site Visit Report Timeline (DOC, 62KB)
      Use to identify standard timeframes for distribution of site visit reports (initiation, annual/interim or close-out).
Close Out/Step 4

Standard Operating Procedures

The standard operating procedures (SOPs) listed below are written to help study staff close-out a Cancer Prevention Clinical Trial.

SOP #1: Conducting Close-out Visits at Participating Organizations

  • Responsibilities (SOP) (DOC, 46KB)
    Lists the Consortia responsibilities in the conduct of the close-out site visit at the participating organizations.
  • Checklists/Documents

SOP #2: Study Close-Out

SOP #3: Final Database Lock and Final Data Delivery