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Sop 603 Capa

This 3-page standard operating procedure establishes a Corrective and Preventative Action (CAPA) Plan for clinical research conducted at Kent State University. The CAPA Plan provides a systematic process to identify issues, investigate root causes, and implement actions to prevent recurrence. The principal investigator is responsible for oversight, but may delegate tasks to clinical research team members. The procedure outlines triggers for a CAPA Plan, principles for an effective plan, and requirements for documenting issues, analyses, and follow-up actions using a CAPA Plan Response Form.

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90 views

Sop 603 Capa

This 3-page standard operating procedure establishes a Corrective and Preventative Action (CAPA) Plan for clinical research conducted at Kent State University. The CAPA Plan provides a systematic process to identify issues, investigate root causes, and implement actions to prevent recurrence. The principal investigator is responsible for oversight, but may delegate tasks to clinical research team members. The procedure outlines triggers for a CAPA Plan, principles for an effective plan, and requirements for documenting issues, analyses, and follow-up actions using a CAPA Plan Response Form.

Uploaded by

isralmayoor
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Standard Operating Procedures for Clinical Research at Kent State University

CORRECTIVE AND PREVENTATIVE ACTION PLAN

Effective Date: Revision Date:


SOP#: 603 Version: 1.0 Page: Page 1 of 3

PURPOSE: The purpose of this SOP is to establish a Corrective and Preventative Action
(CAPA) Plan for conducting and documenting internal activities for continual assessment of
compliance with clinical trials conducted at KSU.

SCOPE: This SOP applies to the PI and designated clinical research personnel involved in the
regulatory implementation and coordination of clinical trials at KSU.

RESPONSIBILITY: The PI is responsible for the overall conduct of a research study at KSU,
however; delegation allows clinical research team members to perform CAPA activities under
the direct supervision of the PI in the implementation and conduct of clinical trials.

DEFINITIONS:

Audit: A systematic and independent examination of trial related activities and documents to
determine whether the evaluated trial related activities were conducted, and the data were
recorded, analyzed and accurately reported according to the protocol, sponsor’s standard
operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory
requirement(s).

Corrective action: Action to eliminate the cause of an identified problem or deviation.


Corrective action is taken to prevent recurrence.

Corrective and Preventive Action (CAPA): The processes taken and process improvements
initiated to eliminate causes of nonconformities or other undesirable situations.

Monitoring: The act of overseeing the progress of a clinical trial, and of ensuring that it is
conducted, recorded, and reported in accordance with the protocol, Standard Operating
Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory
requirement(s).

Monitoring Report: A written report from the monitor to the sponsor after each site visit and/or
other trial-related communication according to the sponsor’s SOPs

Preventive Action: An action to eliminate the cause of a potential non-conformity or other


undesirable potential situation. Preventive action is taken to prevent occurrence.

Root Cause Analysis: A class of problem solving methods used to identify the root causes of
problems or events.
Standard Operating Procedures for Clinical Research at Kent State University

CORRECTIVE AND PREVENTATIVE ACTION PLAN

Effective Date: Revision Date:


SOP#: 603 Version: 1.0 Page: Page 2 of 3

PROCEDURE:

1. Research personnel will be aware that a Corrective and Preventative Action (CAPA)
Plan can be triggered in a number of ways that may include:
 During a Site Initiation Visit (SIV) or Routine Monitoring Visit (RMV) when a
monitor reports that a site requires a “for cause” or “not for cause” audit.
 During an internal audit
 During an FDA audit
 Preventative actions for potential problems and issues

2. To minimize the need for a CAPA, research personnel will maintain ongoing training
requirements necessary to work in research and comply with the Standard Operating
Procedures (SOPs) of KSU.

3. Research personnel will recognize that a CAPA plan can include more than one activity
and issue whereas, a Note to File (NTF) usually addresses one problem or issue that
has occurred.

4. Research personnel will adhere to the following principles when developing and
executing a CAPA plan:
4.1. The plan should make sense.
4.2. The plan should be easily implemented and managed.
4.3. The plan must be systematic and measurable. It must be proactive and able to
correct problems at all levels of the research site. It should be easy to use and
track progress of the action to be able to show results that are working.
4.4. The plan should account for more than a reaction to problems. It should have the
potential to improve efficiency and effectiveness of the clinical trial.

5. Research personnel will complete a CAPA Plan Response Form (Appendix JJ) that
includes the following when preparing a CAPA plan:
5.1. Identify: Pinpoint the problem or potential problem.
5.2. Evaluate: Assess the magnitude and impact of the problem.
5.3. Investigate: Research the problem.
5.4. Analyze: Perform a root cause analysis of the problem.
5.5. Act: Create a list of required actions and due dates to eliminate the problem and
prevent recurrence.
5.6. Implement: Execute the action plan and track action item, responsibilities and
completion status
Standard Operating Procedures for Clinical Research at Kent State University

CORRECTIVE AND PREVENTATIVE ACTION PLAN

Effective Date: Revision Date:


SOP#: 603 Version: 1.0 Page: Page 3 of 3

5.7. Follow-up: Verify and assess the effectiveness of the plan. Make changes to the
plan if needed.

FDA Guidance for Industry: Guideline for the Monitoring of Clinical


Investigator.
FDA Guidance for Industry: Investigator Responsibilities – Protecting the
Rights, Safety and Welfare of Study Subjects. October 2009
21 CFR 312
21 CFR 812
REFERENCES: 21 CFR 820, Subpart J: Corrective and Preventive Action Requirements
ICH Guideline E6: Good Clinical Practice
RELATED POLICIES:

APPENDICES:

REVISION HISTORY: Keep a running history of all revision dates.


Approval Date Effective Date Review/Revision Date

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