Sponsor/CRO Responsibilities

Sponsor/CRO Responsibilities

The ethical principles employed by IntegReview that govern the conduct of human research are those identified in the Belmont Report; respect for persons, beneficence and justice. IntegReview expects Sponsors and CROs to abide by these principles as well.

It is the responsibility of the Sponsor/CRO to:

  • Follow any federal, as well as any applicable state and local laws governing research
  • Provide any safety information to IntegReview, which may help to provide additional protections for research participant’s safety and well-being.
  • Ensure procedures are used to maintain the confidentiality of the research data.
  • Ensure the privacy of research participants is protected.
  • Incorporate plans to monitor the data collected for the safety of research participants. Monitoring might occur at specific points in time, after specific numbers of participants have been recruited, or upon recognition of harms.
  • Report findings detected in the monitoring process when those findings could affect the safety of participants or their willingness to continue participation, influence the conduct of the study, or alter IntegReview’s approval to continue the study.
  • When an IND or IDE is required, per Title 21, CFR, §312.20(b), a clinical investigation, to include screening and recruitment, shall not begin until the investigation is subject to an IND which is in effect. Therefore, IntegReview will hold the informed consent document and recruitment materials, as applicable, until the IND number is received.

Per Title 21, CFR, §812.42 – same as above applies for significant risk device studies and the requirement for the IDE to be effective.

You may obtain answers to questions, express concerns, and convey suggestions regarding IntegReview’s Human Research Protection Program (HRPP) via e-mail to Melanie Flores, Director of Compliance or by dialing (512) 326-3001, extension 209.

We welcome you to complete IntegReview’s Customer Survey to offer suggestions or to voice any concerns regarding our processes or services. Customer surveys that reflect concerns will be reviewed by IntegReview Management.