IRB Process and Reporting
Guidance and requirement for developing appropriate informed consent and/or assent; information on standard statements and waivers.
Information about the continuing review; preparing the packet, instructions and appropriate forms to renew a protocol.
Guidance and procedures to close a research study.
Procedures and forms to submit revisions to the protocol, consent or Investigator's Brochures.
Reporting guidelines and forms for internal and external adverse events.
Regulatory requirements, guidance and forms for submitting protocol deviations, violations and unanticipated problems.
Recruitment guidelines and forms for advertisements submitted for IRB-approval
