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Introduction

This page provides information on C3D data transfer capabilities and provides steps for setting up data transfer infrastructure for external sponsors.

Background

CCR conducts clinical trials that are sponsored by Pharmaceutical companies or for which Pharmaceutical companies provide the experimental treatment. As a part of the arrangement, CCR provides datasets to the sponsor for their analysis and reporting. C3D can be used as a data collection tool for these trials and the resulting datasets could be made available to the sponsors either at the end of the study or on an ongoing schedule via a mutually share secure File Transfer arrangement.

Steps

  1. Initial discussions regarding using C3D as a data capture tool for the Pharmaceutical Sponsored upcoming study happens typically during the Clinical Trial Agreement (CTA) or Cooperative Research and Development Agreement (CRADA).
  2. Sponsors are interested in overall C3D capabilities and certifications. As a part of the initial discussion, they should be made familiar with the following information:
    1. Quick Overview of C3D: A short powerpoint presentation on C3D capabilities
    2. C3D 21 CFR Part 11 Compliance Statement
    3. CCR Standard Case Report Forms: CCR studies are built leveraging the standard eCRFs - sponsor specific needs can be met to the extent of adding additional questions, sections, or forms to capture concepts not covered by CCR standards
  3. If the sponsor needs to have further discussion on the topic, please contact XXX for arranging a teleconference or meeting. It is ideal to meet in person for 1/2 hour while the sponsor representative is at CCR for protocol meetings.
  4. Protocol should indicate C3D as the Data Capture tool.
  5. Sponsor representatives can participate in the review of the database design via the Study coordinator, who provide the principal interface between C3D programmer/analysts and the Study Team.
  6. Protocol representatives needing access to C3D will need to attend 90 minute web-based training and sign confidentiality agreement. Study coordinator should coordinate the training request via training website.
  7. Sponsor needs to identify primary and secondary points of contact for data-transfer discussion.
  8. CCR Clinical Informatics representative negotiates a data transfer site with the sponsor - it could be an existing file transfer mechanism used by the sponsor or a secure File Transfer Protocol (FTP) based site provided by NIH.
  9. Protocol Annotation Report, Dataset Definition files, and test data files are made available on the data transfer site for sponsor to review.
  10. Upon activation of the protocol, data transfer is initiated based on the agreed frequency of the transfer.
Last updated by Paul, Rohit (NIH/NCI) [C] on Nov 19, 2017