Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials. Addendum to ICH E6(R1). Guidance for Industry. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation. Current effective version. PDF icon Revision 2 - Adopted guideline. Reference number, EMA/CHMP/ICH// Published, 15/12/ Effective from, 14/06/ .
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international guidelines, including GCP guidelines issued subsequent to , such as the International Conference on Harmonization (ICH). Good Clinical. The purpose of these WHO Guidelines for Good Clinical Practice (GCP) for trials on pharmaceutical products is to set globally applicable standards for the. Page 1. The 13 principles of ICH GCP. Clinical)trials)should)be)conducted)in) accordance)with)the)ethical)principles)that).
Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task s. Freely given informed consent should be obtained from every subject prior to clinical trial participation. All clinical trial information should be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification.
The ICH GCP addendum adds to this principle, stating that it applies to all records referenced in the guideline, irrespective of the type of media used. This addendum is aimed at advances in technology—the proliferation of the internet, smartphones, electronic data capture, real-time review of clinical data—that have fundamentally changed the conduct of clinical trials.
The confidentiality of records that could identify subjects should be protected respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement s.
Investigational products should be manufactured, handled and stored in accordance with applicable good manufacturing practice GMP. They should be used in accordance with the approved protocol.
Systems with procedures that assure the quality of every aspect of the trial should be implemented. The ICH GCP addendum emphasizes that aspects of the trial that are essential to ensure human subject protection and reliability of trial results should be the focus of such systems.
In other works, these systems should be risk-based. MHRA will agree an inspection date and give you information on the inspection team and the practical logistical aspects of the inspection.
Occasionally, after reviewing the dossier, the lead inspector may decide not to proceed with the inspection. The complete TMF is the basis for inspection and all the documents in it must be made available to the inspectors. This includes any electronic documents and emails.
You can discuss with the lead inspector beforehand on how to make the TMF available during the inspection. If you have problems meeting these requirements, you should tell the lead inspector before the inspection. Failure to provide the TMF can affect the results of your inspection.
The inspection plan The inspection plan is based on discussions with you and the information provided in your GCP inspection dossier, to ensure all activities are covered. Appropriate people should be available for interview either in person or by teleconference.
Additional supporting documentation such as line listings, database extracts, floor plans etc.
All documentation requested should be provided within the time agreed with the lead inspector. Inspectors will be flexible with the inspection plan to accommodate working patterns of individuals and immediate issues if they arise.
An inspection plan will be given to you in advance and any comments or questions relating to it can be discussed with the lead inspector. During the inspection The inspection includes interviews with relevant people and a review of the documentation, such as the TMF.
The inspector may visit: data management units.