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Consortia Source Documentation Guide
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Clinical Trials Resource Step-by-Step
Instructions for Consortia Members

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

2003 DCP Consortia for Early Phase Prevention Trials

  • Step 2 Conducting

    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

    Responsibilities (SOP) (doc, 64kb)
    Lists the Consortia responsibilities during collection and submission of regulatory documents.

    Checklists/Documents

    Checklist for Initial Submission of Regulatory Documents (doc, 194kb)
    Use as a tool for planning and tracking collection and submission of regulatory documents.

    DCP Document Transmittal Form (doc, 41kb)
    Use to track document submissions between Participating Organizations and CLO.

    Checklist for Subsequent Submission of Regulatory Documents (doc, 79kb)
    Use as a tool for planning and tracking collection and submission of regulatory documents required throughout the course of study.

  • 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

    Screening Log (doc, 41kb)
    Use to track screening status for studies not yet available in DCP Oracle Clinical (OC) Remote Data Capture (RDC).

    Recruitment Retention and Adherence Plan Template (doc, 46kb)
    Use this template as a guide when writing the Recruitment, Retention and Adherence (RRA) plan.

  • SOP #4 Recording and Reporting Protocol Deviations

    Responsibilities (SOP) (doc, 46kb)
    Lists the Consortia responsibilities during recording and reporting of protocol deviations.

    Checklists/Documents

    DCP Consortia Protocol Deviation Form (doc, 80kb)
    Use to record and report 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 (doc, 80kb)
    Use to report and track Serious Adverse Events (SAEs).

    Serious Adverse Event Form Instructions for Completion (doc, 135kb)
    Use as a reference to complete the DCP Serious Adverse Event Form.

    Summary of Reporting Responsibility for Serious Adverse Events (SAEs) (doc, 41kb)
    Use as a reference to review SAE reporting responsibilities for CLO and Participating Organization staff.

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

    Responsibilities (SOP) (doc, 50kb)
    Lists the Consortia responsibilities using updated versions of pCRFs and eCRFs.

    Checklists/Documents

    Division of Cancer Prevention (DCP) Policy for DCP Consortia Studies: Case Report Form Versioning Policy (doc, 48kb)
    Use as a reference to clarify DCP's policy and procedures for versioning and dating CRFs.

  • 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.

  • Step 3 Monitoring

    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

    Site Monitoring Training Checklist (doc, 50kb)
    Use to indicate the completion of training requirements for new on-site monitors.

  • 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

    Responsibilities (SOP) (doc, 71kb)
    Lists the Consortia responsibilities during the conducting of annual/interim visits.

    Checklists/Documents

    Clinical Site Annual (Interim) Monitoring Report (doc, 130kb)
    Use to document findings of annual/interim site monitoring visits. It can also be used as a preparation worksheet for annual/interim visit tasks.

    Pharmacy Visit Report (doc, 82kb)
    Use to document findings of pharmacy visits. It can also be used as a preparation worksheet for pharmacy visit tasks.

    Site Monitoring Visit Log (doc, 46kb)
    Use to document monitor and site staff attendance during the site visit.

    Per PID Finding Sheet for On-Site Chart Review (doc, 45kb)
    May be used as a communication tool for findings per participant.

    Preliminary Report of Monitoring Findings (doc, 47kb)
    Use to document initial findings of an annual/interim site visit.

    Examples of Major and Lesser Deficiencies (doc, 104kb)
    Use as a guide to categorize severity of deficiencies found during a site monitoring visit.

    Site Visit Report Timeline (doc, 62kb)
    Use to identify standard timeframes for distribution of site visit reports (initiation, annual/interim or close-out).

    Action Item - Site Response Form (doc, 52kb)
    May be used to list action items from a site visit and capture site responses.

  • 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).

  • Step 4 Closing Out

    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

    Clinical Site Annual (Interim) Monitoring Report (doc, 130kb)
    Use in addition to the Clinical Site Close-out Visit Report if chart reviews were performed in addition to the close-out visit.

    Clinical Site Close-Out Visit Report (doc, 58kb)
    Use to document findings from the clinical site close-out visits. It can also be used as a preparation worksheet for monitoring tasks during the close-out visit.

    Site Monitoring Visit Log (doc, 46kb)
    Use to document monitor and site staff attendance during the site visit.

    Site Visit Report Timeline (doc, 62kb)
    Use to identify standard timeframes for the distribution of the site visit reports (initiation, annual/interim close-out).

  • SOP #2: Study Close-Out

    Responsibilities (SOP) (doc, 48kb)
    Lists the Consortia responsibilities during study close-out.

    Checklists/Documents

    DCP Study Status Update Form (doc, 33kb)
    Use to communicate the status of the study to the sponsor and all other applicable organizations and staff.

    Checklist for Study Close-Out (doc, 65kb)
    Use as an optional tool for planning and communicating the project and completion dates for study close-out tasks.

    DCP OC-RDC CLO Data Lock Checklist/Request (doc, 61kb)
    Use as a tool to prepare the database for study close-out.

  • SOP #3: Final Database Lock and Final Data Delivery

    Responsibilities (SOP) (doc, 63kb)
    Lists the Consortia responsibilities during final database lock and final data delivery.

    Checklists/Documents

    Checklist for Study Close-Out (doc, 65kb)
    Use as an optional tool for planning and communicating the project and completion dates for study close-out tasks.

    DCP OC-RDC CLO Data Lock Checklist/Request (doc, 61kb)
    Use as a tool to prepare the database for study close-out.

  • Guide to DCP Study Close-Out: Milestones and Tasks
    This Guide incorporates the above SOPs and can assist planning for study close-out.

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