GCDMP© CHAPTERS

EVIDENCE BASED CHAPTERS

Abstract

Every clinical study should have prospective plans for how data will be collected, processed and stored. Likewise, every study should have defined data elements and objective evidence of how data were processed. This chapter outlines the purpose of, and regulatory basis for, such documentation in the form of a Data Management Plan (DMP).

After reading this chapter, the reader should understand:

  • The purpose of and regulatory basis for the DMP
  • The contents and organization of the DMP
  • Creation and maintenance of the DMP

Abstract

Case Report Forms (CRF) completion is one of the earliest opportunities to assure accurate and complete data and to decrease downstream work associated with identification and resolution of data discrepancies. This chapter covers development, maintenance, and implementation of instructions for CRF completion, also called CRF Completion Guidelines (CCGs).

After reading this chapter, the reader should understand:

  • The purpose of an regulatory basis for CRF completion guidelines
  • The contents and organization of CRF completion guidelines
  • Creation and maintenance of CRF completion guidelines
  • Training clinical investigational sites and CRAs on CCGs

CONSENSUS-BASED CHAPTER

Abstract

Vendors provide services that are critical to the successful outcome of a clinical study, yet sponsors retain the ultimate responsibility for activities that are outsourced. Thus, if a sponsor delegates study activities to a vendor or a vendor’s vendor and so on, the sponsor should take measures to ensure the vendor and any subcontractors are consistently delivering products or services of acceptable quality. This chapter provides recommendations for evaluating, selecting, and providing oversight of vendors to determine whether their services adequately meet Sponsor expectations including quality requirements and regulatory standards.

After reading this chapter, the reader should understand:

  • The purpose of and regulatory basis for vendor selection and management
  • Differences in outsourcing and contracting models
  • Processes for vendor selection
  • Contents and organization of a vendor scope of work (SOW)
  • Processes for vendor oversight
  • Governance models for strategic partnerships