Users' questions

What are the three requirements of ICH GCP for conducting a clinical trial?

What are the three requirements of ICH GCP for conducting a clinical trial?

1.1 Adverse Drug Reaction (ADR)

  • 1.2 Adverse Event (AE)
  • 1.3 Amendment (to the protocol)
  • 1.4 Applicable Regulatory Requirement(s)
  • 1.5 Approval (in relation to Institutional Review Boards)
  • 1.6 Audit.
  • Which documents are required for investigator files?

    Signed consent forms. Source documents – document the existence of the patient and verify integrity of data collected. Completed, signed and dated case report forms (CRF) and corrections to CRF. Serious adverse events reports.

    What essential documents are needed to conduct clinical trials?

    The essential documents for clinical trials are the following: Investigator’s Brochure. Clinical Study Protocol. Subject Information and Informed Consent Form….CLINICAL STUDY PROTOCOL

    • Study Plan.
    • Study schedule.
    • Study Visits.
    • Study Assessments / Procedures.
    • Definition of efficacy endpoints.
    • Treatment cycles.

    What are the ICH GCP guidelines?

    The ICH-GCP is a harmonised standard that protects the rights, safety and welfare of human subjects, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public.

    What do you need to know about ICH GCP?

    To document that tests remain adequate throughout the trial period (see 8.2.12) (see 8.2.15.) To document that consent is obtained in accordance with GCP and protocol and dated prior to participation of each subject in trial. Also to document direct access permission (see 8.2.3)

    Where can I Find my ICH essential documents?

    Any or all of the documents addressed in this guideline may be subject to, and should be available for, audit by the sponsor’s auditor and inspection by the regulatory authority (ies). The sponsor and investigator/institution should maintain a record of the location (s) of their respective essential documents including source documents.

    What are the requirements for Ich item 8.1?

    Item 8.1 also requires that the storage system used during the trial and for archiving after the trial (irrespective of the type of media used) provides clear document identification, version history, and search and retrieval functionalities.

    When was the ICH GCP E6 ( R2 ) adopted?

    The changes brought by the International Council for Harmonization’s (ICH) E6 (R2) addendum to its Guideline for Good Clinical Practice (GCP) and the subsequent adoption by the European Medicines Agency effective June 14, 2017, have had a significant impact on sponsors, contract research organizations (CROs), and clinical trial sites alike.