The Global Guideline For GCP Audit

Background

ICH GCP has been adopted by three regions and implemented since 1996. The details on GCP auditing are not provided in ICH GCP and there is no global guideline for GCP audit. JSQA thought that the global guideline for GCP audit was necessary to harmonize GCP auditing for the quality assurance of global clinical studies. JSQA looked at ENGAGE (The European Forum for Good Clinical Practice) Auditing Guideline (1998 and 2005), ICH Proposed Guideline for GCP compliance and Quality
System Auditing (1993), ISO 9000 Quality management systems-Fundamentals and vocabulary (2000), ISO 19011 Guidelines for quality and/or environmental management auditing (2002), etc. to get the benefits of them.
JSQA completed the “JSQA Guideline for GCP Auditing” and announced it at 1st GQAC in 2005 as a poster session.
JSQA published “JSQA Guideline for GCP Auditing” on QA Journal of SQA in 2007 (QAJ 403) in order to promote the global discussion for the harmonization of GCP audit.
JSQA proposed the global discussion for Global Guideline for GCP Audit among SQA, BARQA and JSQA in November 2007 at the BARQA annual conference. The global project members were identified and had the kick-off meeting in April 2008 at the 24th SQA annual meeting. The global project members had meetings in October 2008 at 2nd GQAC in Edinburgh and in April 2009 at the 25th SQA annual meeting to discuss the guideline.

This guideline was completed based on the global discussions among SQA, BARQA and JSQA. The guideline includes the mission and the organization of a sponsor’s auditing department and establishes the principles for planning, performing, and reporting audits. The guideline is expected to be a basic principle along with ICH GCP for not only sponsor’s auditors, but also independent auditors and auditors of Contract Research Organizations (CROs) to conduct an audit in the various situations of each country and sponsor.

Table of Contents
1 Scope of the Guideline
2 Definitions

3 Mission of a Sponsor’s Auditing Department
4 Auditing Department
4.1 Independent Auditing Department
4.2 Qualified Auditors
4.3 Qualifications of Auditors
4.4 Responsibilities of Auditors

5 Planning of Audits
5.1 Establishing the Goals of an Audit
5.2 Designing and Updating the Audit Plan
5.3 Determining the Subject(s), Timing, and Method(s) of an Audit
5.4 Information in the Audit Plan

6 Conduct of an Audit
6.1 Explaining the Auditing Procedures
6.2 Conducting an Audit and Collecting information
6.3 Confirmation and Evaluation of Audit Observations

7 Reporting the Results of an Audit
7.1 Preparation of an Audit Report
7.2 Persons to whom Audit Reports are submitted

8 Corrective and Preventive Actions
9 Completion of an Audit
10 Audit Certificate

11 Keeping Audit Records

Author: JSQA:
Hiroyasu Yamashita.
Reviewed and Acknowledged by:
BARQA:
Patricia Fitzgerald
SQA:
MaryEllen Lander

Clinical Research News

Prossimi studi clinici

  • NCT04941261
    Reclutamento
    Condizioni: Norovirus Infections, Gastroenterite di Norwalk
  • NCT04853836
    Non ancora reclutando
    Condizioni: Anosmia, Covid19, iposmia, parosmia, Conformità al trattamento
  • NCT02834013
    Reclutamento
    Condizioni: Acinar Cell Carcinoma, Carcinoma adenoide cistico, Carcinoma della corteccia surrenale, Feocromocitoma della ghiandola surrenale, Carcinoma neuroendocrino del canale anale, Carcinoma indifferenziato del canale anale, Angiosarcoma, Neoplasie Apocrine, Appendice Adenocarcinoma mucinoso, Carcinoma a cellule di transizione della ghiandola di Bartolini, Carcinoma delle cellule basali, Adenocarcinoma della vescica, Carcinoma metaplastico al seno, Adenocarcinoma Cervicale, Adenocarcinoma cervicale a cellule chiare, Colangiocarcinoma, cordoma, Carcinoma squamocellulare colorettale, Fibromatosi Desmoide, Carcinoma a cellule transizionali dell'endometrio, Adenocarcinoma endometrioide, Carcinoma neuroendocrino esofageo, Carcinoma indifferenziato esofageo, Carcinoma del dotto biliare extraepatico, Malattia di Paget extramammaria, Adenocarcinoma delle tube di Falloppio, Carcinoma a cellule di transizione della tuba di Falloppio, Tumore fibromixoide, Carcinoma della colecisti, Carcinoma neuroendocrino gastrico, Carcinoma squamocellulare gastrico, Carcinoma gastrico indifferenziato, Tumore stromale gastrointestinale, Tumore trofoblastico gestazionale, Carcinoma a cellule giganti, Carcinoma neuroendocrino intestinale, Colangiocarcinoma intraepatico, Tumore carcinoide polmonare, Carcinoma sarcomatoide polmonare, Carcinoma maggiore delle ghiandole salivari, Tumori odontogeni maligni, Tumore maligno della guaina del nervo periferico, Neoplasia solida maligna, Tumore stromale del cordone sessuale testicolare maligno, Tumore maligno metastatico di origine sconosciuta Un, Adenocarcinoma polmonare mininvasivo, Tumore misto mesodermico (mulleriano), Adenocarcinoma mucinoso, Cistoadenocarcinoma mucinoso, Adenocarcinoma della cavità nasale, Carcinoma della cavità nasale, Carcinoma nasofaringeo, Adenocarcinoma papillare nasofaringeo, Carcinoma indifferenziato nasofaringeo, Carcinoma del cavo orale, Carcinoma indifferenziato orofaringeo, Adenocarcinoma ovarico, Tumore a cellule germinali ovariche, Adenocarcinoma mucinoso ovarico, Carcinoma ovarico a cellule squamose, Carcinoma ovarico a cellule di transizione, Carcinoma a cellule acinose pancreatiche, Carcinoma neuroendocrino pancreatico, Paraganglioma, Adenocarcinoma del seno paranasale, Carcinoma del seno paranasale, Carcinoma della ghiandola paratiroidea, PEComa, Mesotelioma peritoneale, Carcinoma della ghiandola pituitaria, Coriocarcinoma placentare, Adenocarcinoma sieroso peritoneale primitivo di alto grado, Pseudomixoma peritoneo, Disturbo raro, Carcinoma squamocellulare scrotale, Adenocarcinoma delle vescicole seminali, seminoma, Cistoadenocarcinoma sieroso, Adenocarcinoma del piccolo intestino, Carcinoma squamocellulare del piccolo intestino, Neoplasie delle cellule del fuso, Carcinoma squamocellulare del pene Pen, Teratoma con tumore maligno di tipo somatico, Tumore a cellule germinali testicolare non seminomatoso, Carcinoma della tiroide, Carcinoma tracheale, Carcinoma a cellule di transizione, Adenocarcinoma dell'uretere, Carcinoma a cellule squamose dell'uretere, Adenocarcinoma uretrale, Carcinoma a cellule squamose uretrale, Adenocarcinoma vaginale, Carcinoma a cellule squamose vaginale, non altrimenti specificato, Carcinoma vulvare
  • NCT04316559
    Reclutamento
    Condizioni: Disturbo da uso di oppioidi
  • NCT04629664
    Reclutamento
    Condizioni: Hearing Loss, Sensorineural, Astma a przewlekła choroba powodująca zwężenie dróg oddechowych. Osoby z astmą mogą wystąpi świszczenie, klatki piersiowej w klatce piersiowej i trudności w oddychaniu. Asma scherzo problema główny zdrowia publicznego wśród Portorykańczyków, badniki badań w celu ustalenia dziedziczności i środowiska na chorobę w tej części. Uczyć się więcej Jeśli chodzi o te związki, to badanie zbada wpływ niektórych genów i genów na temat rozwoju i ciężkości astmy u dzieci z Puerto Rico. W tym badaniu obserwacyjnym rekrutowane będą z astmą, jak i dzieci bez astmy. W trakcie badania ucznia spotkają się z personelem badawczym. Pierwsza wizyta odbędzie się miejsce w domach uczniów. Uczestnicy wypełnią ankiety dotyczące danych demograficznych, układ oddechowy i ogólny stan zdrowia oraz charakterystyka gospodarstw domowych. Badanie czynności płuc, pobór krwi, a także kurz domowy odbędzie się o godz wizyta domowa. Druga, wizyta odbędzie się w ośrodkach gospodarczych. Podczas tej rozmowy uczestnicy przejdą testy alergiczne na skórze i test prowokacyjny na metacholinę Ocenianie odcinków dróg oddechowych i ciężkość astmy. Prova prowokacyjny na metacholinę będzie polegają na wdychaniu mgiełki przez ustnik i silnym dmuchaniu do specjalnego instrumentu zwany spirometri. Rodzice poproszeni o podanie informacji o swoich dzieciach szkenie na zwierzęta domowe we wczesnym okresie życia. Każda wizyta potrwa około 1,5 godziny i będzie zaplanowane blisko wejścia ucznia do badań., Ipoacusia improvvisa
  • NCT03780062
    Reclutamento
    Condizioni: Minor Traumatic Brain Injury, Trattamento con antiaggregante
  • NCT04823988
    Non ancora reclutando
    Condizioni: volontario sano
  • NCT04541992
    Non ancora reclutando
    Condizioni: Infortunio alla gamba
  • NCT04242498
    Reclutamento
    Condizioni: Idradenite suppurativa
  • NCT04086485
    Non ancora reclutando
    Condizioni: Gastroenteropancreatico Tumors, Tumori neuroendocrini, Neoplasie Neuroendocrine