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SOP 601 QualityControl

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29 views3 pages

SOP 601 QualityControl

Uploaded by

qualidade
Copyright
© © 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

QUALITY CONTROL

Effective Date: Revision Date:

SOP#: 601 Version: 1 Page 1 of 3

PURPOSE: This Standard Operating Procedure (SOP) describes the methods of Quality
Control (QC) for clinical studies conducted at KSU.

SCOPE: This SOP applies to the all clinical studies conducted at KSU.

RESPONSIBILITY:

Investigator: The PI is responsible for maintaining and enforcing a quality system for all
research studies conducted at KSU. He/ She delegates the implementation and supervision of
QM activities to designated research personnel who are trained and qualified to perform these
delegated tasks.

Clinical Research Coordinator and Key Personnel: The study coordinator and other key
research personnel are responsible for the development of quality measures and activities
specific to their area and need that include adherence to written SOPs, training, and ongoing
assessment of use, need and validity.

DEFINITIONS:

Corrective and Preventive Actions (CAPA): A system for implementing corrective actions and
preventive actions resulting from the investigation of complaints, product rejections, non-
conformances, recalls, deviations, audits, regulatory inspections and findings, and trends from
process performance and product quality monitoring.

Good Clinical Practice (GCP): A standard for the design, conduct, performance, monitoring,
auditing, recording, analyses, and reporting of clinical trials that provides assurance that the
data and reported results are credible and accurate, and that the rights, integrity, and
confidentiality of trial subjects are protected.

Quality Assurance (QA): All those planned and systematic actions that are established to
ensure that the trial is performed and the data are generated, documented (recorded), and
reported in compliance with GCP and the applicable regulatory requirement(s).

Quality Control: Continuous operational checks within each functional department to verify that
clinical data are generated, collected, handled, analyzed, and reported according to protocol,
SOPs, and Good Clinical Practices (GCPs).

PROCEDURE:

1. Research staff will ensure compliance with the established SOPs, FDA requirements,
sponsor’s protocol and local regulatory authorities.
Standard Operating Procedures for Clinical Research at Kent State University

QUALITY CONTROL

Effective Date: Revision Date:

SOP#: 601 Version: 1 Page 2 of 3

2. Staff training of Human Subjects Research Protection, GCP, SOPs and federal/local
regulatory requirements will be performed and documented.

PROCEDURE (cont.):

3. Research personnel will utilize standardized forms and checklists to ensure documentation
is accurate and complete.

4. Study personnel will conduct periodic internal QAs/ reviews to ensure compliance with KSU
SOPs, GCPs, regulatory, protocol requirements and data accuracy.
 QA checks can be done by any research staff member.
 Internal quality control forms will be completed randomly.
 Deficiencies found through internal QA or sponsor monitoring visits will be corrected.
 QA checks will be performed annually at a minimum.
 An internal QC binder will be maintained by the research staff.

5. Documentation for each study will be reviewed periodically throughout the study using FDA
audit criteria to ensure that is adequate and accurate. This includes:
 Who performed each task
 Degree of delegation of authority by PI
 How and where data were recorded
 Verification of protocol adherence
 How study test article accountability and dispensation are/were maintained
 Communications between sponsor and PI
 IRB documentation, communications and approvals
 Signed, IRB stamped consent forms for each subject with correct version
 Accurate and complete report of adverse events followed to resolution or satisfactory
endpoint
 CRF form verification with source documentation and other records
 Record retention consistent with GCPs and sponsor requirements

6. The PI and study coordinator will review sponsor monitoring reports and correspondence to
assess errors and develop a CAPA plan to prevent further errors

7. Documentation of periodic quality reviews that contain confidential information for continued
QA should be maintained separately from official study records.

8. Research management will review quality QA checks to ensure continued research quality
and training needs of all research personnel are met.
Standard Operating Procedures for Clinical Research at Kent State University

QUALITY CONTROL

Effective Date: Revision Date:

SOP#: 601 Version: 1 Page 3 of 3

PROCEDURE (cont.):

9. Research management will review quality QA checks to ensure continued research quality
and training needs of all research personnel are met.

10. After QA checks and internal audits, the PI and study coordinator will specify a timeline
within which any corrective actions should be made. This should not take longer than 2
weeks but may vary depending on the nature of the particular findings.

11. Study staff will not make documentation of such internal quality reviews available during
Sponsor audits. The FDA may have access to these records by a court ordered subpoena.

21 CFR 312.60 General Responsibilities of Investigators


21 CFR 312.62 Investigator recordkeeping and record retention
21 CFR 312.64 Investigator reports
21 CFR 312.66 Assurance of HRRC review, September 1993,
FDA Clinical Investigator Inspections: October 1998
International Conference on Harmonization; Good Clinical Practice:
REFERENCES: sections 1.46-1.47, 1.6

RELATED POLICIES:

APPENDICES:

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

Approval Date Effective Date Review/Revision Date


01/29/2017

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