FDA / ICH reference questions

**Fast regulation search** Searched the local FDA/ICH regulation database and found **6 matching sources** for: _What are the investigator qualification requirements?_ --- ## Source 1: 4.3 — Medical Care of Trial Subjects **Reference:** `ICH GCP E6(R2) Section 4.3` **Category:** Medical **Match Score:** 0.8455 4.3.1 A qualified physician (or dentist, when appropriate), who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions. 4.3.2 During and following a subject's participation in a trial, the investigator/institution should ensure that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial. The investigator/institution should inform a subject when medical care is needed for intercurrent illness(es) of which the investigator becomes aware. --- ## Q&A 2: What is Form FDA 1572? **Category:** Regulatory **Source:** `21 CFR 312.53` **Answer:** Statement of Investigator — a legal agreement documenting the investigator's qualifications, commitment to follow protocol and GCP, and delegation of tasks. Required for IND studies. Per 21 CFR 312.53. --- ## Source 3: ICH E6(R2) — Adverse Event (AE) and SAE Reporting **Reference:** `ICH GCP E6(R2) + 21 CFR 312.32` **Category:** Safety **Match Score:** 0.6755 All adverse events (AEs) observed or reported during a clinical trial must be recorded in the CRF and in source documents. Serious Adverse Events (SAEs) must be reported to the sponsor within 24 hours of the investigator's knowledge. The sponsor must then notify all participating investigators, IRBs/IECs, and regulatory authorities according to local requirements. Fatal or life-threatening SAEs must be reported to FDA within 7 days (for investigational new drugs) and other SAEs within 15 days. The investigator must follow SAEs until resolution or stabilization. --- ## Source 4: 21 CFR 312.53 — Selecting Investigators and Monitors **Reference:** `FDA 21 CFR 312.53` **Category:** Regulatory **Match Score:** 0.6614 §312.53 (a) The sponsor shall select only investigators who are qualified by training and experience as appropriate experts to investigate the drug. (b) The sponsor shall obtain a signed and dated Statement of Investigator (Form FDA 1572) from each investigator. (c) The sponsor shall select monitors with appropriate qualifications to monitor the study. (d) The sponsor shall promptly notify an investigator of any new observations regarding adverse reactions or other potential risks. --- ## Q&A 5: What is an Investigator's Brochure (IB)? **Category:** GCP Basics **Source:** `ICH GCP Section 7` **Answer:** A comprehensive document summarizing all available clinical and non-clinical data about an investigational product. Must be updated annually and provided to investigator before trial starts. Per ICH GCP Section 7. --- ## Source 6: 8.0 — Essential Documents for the Conduct of a Clinical Trial **Reference:** `ICH GCP E6(R2) Section 8.0` **Category:** Documentation **Match Score:** 0.6423 8.0 Essential documents are those documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of GCP and with all applicable regulatory requirements. Essential documents include: Before Trial Phase: Signed protocol and amendments, sample CRF, IB, signed consent form, IRB/IEC approval, regulatory authorization, CVs of investigators, financial disclosure, insurance statement, signed agreement between sponsor and investigator. During Trial Phase: CRFs, signed informed consent forms, source documents, subject screening log, subject identification code list, subject enrolment log, serious adverse event reports. After Trial Phase: Trial data archival, audit certificates, final trial report. --- *Tip: Try rephrasing your question for more targeted matches.*