Monitoring vs. Auditing at Investigator Sites ICH GCP (R2) Impact on Investigator Sites

Transcription

1 Monitoring vs. Auditing at Investigator Sites ICH GCP (R2) Impact on Investigator Sites Trini Ajazi, MM, Chief Administrative Officer CRP Breakout Session November Aiance Meeting 2017

2 Agenda Monitoring vs. Auditing ICH GCP impact on Investigator Sites

3 Auditing and Monitoring Defined Monitoring is defined as the act of overseeing the progress of a cinica tria, and ensuring that it is conducted, recorded, and reported in accordance with the protoco, standard operating procedures(sops), GCP, and the appicabe reguatory requirement(s) [ICH 1.38]; and Audit is defined as a systematic and independent examination of tria-reated activities and documents to determine whether the evauated tria-reated activities were conducted, and the data were recorded, anayzed, and accuratey reported according to the protoco, sponsor s standard operating procedures (SOPs), GCP and the appicabe reguatory requirement(s) [ICH 1.6].

4 Monitoring purpose in cinica research Monitoring is a quaity contro function where study conduct is routiney assessed on an ongoing basis at every step of the study. Monitoring of cinica research studies is mandatory per federa reguations (21 CFR812.3 (j), , and ). During the course of a U.S. reguatory audit, FDA has access to monitoring reports and their associated action items.

5 Monitoring purpose in cinica research During a monitoring visit, a aspects of the study at a specific site wi be checked in accordance with a monitoring pan, incuding: informed consent documents eigibiity criteria protoco compiance source document verification for data accuracy query resoution (carification or correction of inaccurate data) occurrence and reporting of adverse events investigationa product accountabiity maintenance of essentia documents oversight by the Cinica Investigator and IRB Monitors must ascertain that the Cinica Investigator is adequatey informed of his or her responsibiities to recruit eigibe subjects and to coect high quaity data.

6 Auditing purpose in cinica research Auditing, a quaity assurance function, is an independent, top-down, systematic evauation of tria processes and quaity contro. Auditors can assess a wider study sampe than monitors and can hep evauate trends at various eves by auditing a singe or mutipe sites, tria vendors and/or the sponsor. Auditors may ook at study design, site/data management, and statistica anaysis. In genera, auditors evauate compiance to recognized standards, i.e., FDA s Code of Federa Reguations, Internationa Conference on Harmonization, Internationa Standards Organization and Standard Operating Procedures.

7 Auditing purpose in cinica research (cont d) Audits are not done continuousy the way that monitoring is performed during a study, but instead are compiance snapshots in time. In addition, audits are not required by the U.S. reguations, but are vountariy performed. Other countries may require audits, ike Japan and those conducting trias under ISO [section 6.11]. Finay, during the course of a U.S. reguatory audit, FDA woud not have access to an auditor s findings.

8 Why do we audit? An audit is a too to assess both the site and the sponsor process for conducting a cinica study. Monitoring is individua to a protoco and a site s performance of the protoco Auditing can assist in determining monitoring effectiveness Determine study team effectiveness Provide an independent assessment Manage non compiant sites Assess inspection readiness

9 Monitoring + Auditing Whie monitoring and auditing are distinct functions, together, they can compement each other to create an additive impact on the overa quaity and integrity of a cinica tria.

10 AFT Monitors and Auditors Monitors from Contract Research Organizations (CROs)/Third Party Organizations (TPOs) with oversight by AFT staff AFT staff or Pharmaceutica Partner representative (PP) may co-monitor Independent auditors from TPOs AFT staff auditor PP may co-audit

11 Changes to ICH GCP (R2) that infuence the investigator Investigator The investigator is responsibe for supervising any individua or party to whom the investigator deegates study tasks conducted at the tria site If the investigator/institution retains the services of any party to perform study tasks they shoud ensure this party is quaified to perform those study tasks and shoud impement procedures to ensure the integrity of the study tasks performed and any data generated The investigator shoud maintain adequate and accurate source documents and tria records that incude a pertinent observations on each of the site s tria subjects. Source data shoud be attributabe, egibe, contemporaneous, origina, accurate, and compete. Changes to source data shoud be traceabe, shoud not obscure the origina entry and shoud be expained if necessary (e.g., via an audit trai).

12 Q & A

13 Thank you for your participation!