GCP: Responsibilities Flashcards
Differentiate between Sponsor and Investigator responsibilities
Who is responsible for ensuring investigational product is used only by individuals who have agreed to participate in clinical trials as evidenced by signed written informed consent?
Investigator
Who confirms reading and understanding information in the investigator’s brochure, including potential risks and side effects of the drug?
Investigator
Who is responsible for providing information needed to conduct the investigation properly?
Sponsor
Who is responsible for verifying doses specified in the protocol were provided to
subjects?
Investigator
Who is responsible for assuring provision of medical care be given to study patients for study related adverse events?
Investigator
Who is responsible for maintaining adequate and accurate records and making study records available for inspection?
Investigator
Who is responsible for selecting qualified Investigators and monitors?
Sponsor
Who is responsible for informing the Investigator when records are no longer need to be retained after completion of a study?
Sponsor
Who is responsible for annual or more frequent written summaries to the IRB/IEC as required by the IRB/IEC?
Investigator
Who is responsible for obtaining agreement from the investigator/institution for adherence to the protocol, to obtain IRB approval, and GCP compliance?
Sponsor
Who is responsible for submitting FDA forms 3454 and 3455?
Sponsor
Who is responsible for assuring that investigational product is used only by the investigator or qualified sub-investigators?
Investigator
Who is responsible for verifying that use of drug by study subjects reconciles the amounts received and returned to the Sponsor?
Investigator
Who is responsible for ensuring Proper Monitoring, IRB Review and
Approval for a clinical trial?
Sponsor
Who is responsible for conducting the study in accordance with the relevant, current protocol?
Investigator
Who is responsible for obtaining informed consent from each subject before entry into the study?
Investigator
Who is responsible for verifying product was stored as specified by the Sponsor and in compliance with applicable regulations?
Investigator
Who is responsible for registering trials and submitting results to ClinicalTrials.gov?
Sponsor (or PI, if designated sponsor-investigator)
Who is responsible for ensuring that the FDA and all participating investigators are promptly informed on significant new adverse effects or risks with respect to the investigational product?
Sponsor
Who will personally conduct or supervise the investigation?
Investigator
Who agrees to not make any changes in the research without sponsor and IRB approval, except to eliminate immediate hazards to human subjects?
Investigator
Who is responsible for submitting Safety Reports (Expedited Reporting), if appropriate, to regulatory authorities?
Sponsor
Who is responsible for reporting adverse events during the study?
Investigator
Who is responsible for manufacturing, packaging, labeling, and coding of the investigational product?
Sponsor
Who is responsible for maintaining drug and device accountability records from manufacturing through use, return and destruction?
Sponsor
Who is responsible for obtaining IRB approval prior to starting any study related activities?
Investigator
Who is responsible for ensuring the investigation is conducted in accordance with the general investigational plan and protocols contained in the IND/IDE; maintain effective IND/IDE?
Sponsor
Who is responsible for promptly reporting to the IRB all changes in the research activity and unanticipated problems?
Investigator
Who is responsible for ensuring requirements relating to obtaining informed consent and IRB review and approval are met?
Investigator
Who is responsible for informing subjects that drugs are being used for investigational purposes?
Investigator
Who is responsible for ensuring that an appropriately qualified IRB will be responsible for initial and continuing review?
Investigator
Who is responsible for verifying that a drug/device was provided only to study subjects?
Investigator
Who is responsible for ensuring they have adequate time and resources to conduct the study properly?
Investigator
Who is responsible for safety reporting (serious and other adverse events, abnormal laboratory values, etc.)?
Investigator
Who is responsible for ensuring that studies are designed by qualified individuals (physicians, statisticians, other clinical scientists)?
Sponsor
Who is responsible for developing a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial?
Sponsor
Who is responsible for completing a Form FDA 1572 (pharmaceutical investigation) or Investigator Agreement (device investigation)?
Investigator
Who is responsible for submitting an annual report to the FDA (IND/IDE)?
Sponsor
Who is responsible for final written summary to the IRB/IEC?
Investigator
Who is responsible for maintaining quality assurance and quality control systems, with written SOPs, for all activities?
Sponsor
Who is responsible for proper storage and handling of study drug/device; accountability, return or destruction of unused study drug?
Investigator
If the Sponsor determines that the IP presents an unreasonable and significant risk to study subjects (significant new AEs), the Sponsor must:
- Discontinue all studies that present the risk
- Notify FDA, all investigators involved, and their IRBs
- Assure return and accounting for all IP, and its return to the Sponsor (or on-site destruction)
Who is responsible for securing compliance?
Sponsor
Who is responsible for providing pre-clinical and clinical study reports in information amendments to the IND/IDE?
Sponsor
Who is responsible for verifying that a device was used for its intended purpose?
Investigator
Who is responsible for providing medical expertise (Medical Monitor)?
Sponsor
Who is responsible for obtaining a signed 1572 (pharmaceutical investigation) or Investigator Agreement (device investigation)?
Sponsor
Who agrees to ensure all associates, colleagues, and employees assisting with the conduct of the study are informed of their obligations, such as transcribing data from the source document to the CRF?
Investigator
Who is responsible for notifying all involved parties, if warranted, of new safety information adversely affecting subject safety or IRB favorable opinion?
Sponsor
Who is responsible for explaining the proper use of the investigational product to subjects?
Investigator
Who is responsible for providing the investigational product only to investigators participating in an investigation?
Sponsor
