Sponsor/CRO Reporting Requirements

Sponsor/ CRO Reporting Requirements

To ensure compliance with the applicable federal regulations as well as International Conference on Harmonisation (ICH), E6: Good Clinical Practice: Consolidated Guideline, and/or IntegReview’s requirements, notification of the following are required for review/approval:

Report Immediately:

  • Changes in research that were initiated without IRB review and approval to eliminate apparent immediate hazards to the human subjects to ensure the continued safety and welfare of subjects
  • Any significant new findings developed during the course of the research and after study completion which may relate to the subject’s willingness to continue participation will be provided to the subjects.
  • Modifications to previously approved documents
  • Receipt of Investigator/Site 483, Determination letter or Warning letter
  • If the Principal Investigator’s license is suspended, revoked, placed on probation or restricted in any state or country
  • Safety information that may help to provide additional protections for subject’s safety and well being, throughout the course of the study and after study completion.
  • Communication of results from a research study to subjects when those results directly affect their safety or medical care
  • Reports of pregnancy
  • Data Monitoring Committee (DMC/DSMB) Reports

Report within 10 (calendar) days of discovery:

  • Unanticipated problems reports – Unanticipated problems should be reported regardless of whether they occur during the study, after the study completion, or after participant withdrawal or completion. Unanticipated problems involving risks to human subjects or others that are (1) unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied; (2) related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures in the research); and (3) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. Examples of problems or events that may meet the definition of unanticipated problems involving risk to subjects or others may include, but are not limited to the following:
  1. Imminent threat of a reportable event that has not yet occurred
  2. Information indicating a change to the risk/benefit ratio of the research
  3. Death
  4. Breach of confidentiality, including lost or stolen study documents/data
  • Unanticipated adverse device effects, as applicable
  • Non–compliance issues – failure by an investigator and/or sponsor to follow IntegReview’s requirements, applicable regulations or to protect human research subjects, including but not limited to the principles of the Belmont Report
  • Serious non–compliance issues – non-compliance as defined as above and as determined to be serious in a way that adversely affects the rights and welfare of human subjects following the investigation and review by the IRB
  • Continuing non–compliance issues – a pattern of repeated non-compliance or serious non-compliance as determined by the IRB
  • Significant deviations – those that deviate from the approved protocol, informed consent process and affect or can potentially affect the safety of subjects. (IntegReview does not consider protocol deviations to be different from protocol violations)
  • Revisions to the Investigator’s Brochure, as applicable
  • Revisions to the report of prior investigations, as applicable

Submit prior to publication/distribution:

  • Request for modification(s) to the IntegReview approved Informed Consent document(s)
  • Request for new and/or modifications to IntegReview approved recruiting materials

Submit five (5) weeks prior to IntegReview approval expiration date (as indicated on the IRB approval letter):

  • Continuing or periodic (annual) review documents – IntegReview will initiate a reminder 5 weeks, 2 weeks and 1 week prior to IRB approval expiration date

Submit upon completion of study:

  • Notification of study closure

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, Vice President of Compliance or by dialing (512) 326-3001, extension 209.