Office of Human Research Protection Georgia Health Sciences University

Quality Systems approach to ensuring all aspects of research conduct and compliance are addressed

Old Audit◦ Review of all records◦ More of a monitoring

visit◦ Focused on finding

errors

New Assessment◦ Focused on PI oversight

and involvement◦ Looking for trends◦ Focus on compliance and

educating study staff

Level 1◦ Management Controls◦ Personnel Controls◦ Facility Controls

Level 2◦ Investigational product control◦ Safety controls◦ Records, documents and

revision controls Level 3

◦ Corrective and preventative action controls

Facility Facility ControlsControls

InvestigationalInvestigationalProductProductControlsControls Records,Records,

Documents, & Documents, &Revision ControlsRevision Controls

SafetySafetyControlsControls

Personnel Personnel ControlsControls

Corrective &Corrective &PreventivePreventive

ActionsActions

ManagementManagementControlsControls

The PI is ultimately responsible for the conduct of the study and must take an active role in ensuring the study is conducted in compliance with all applicable regulations, policies, and laws. Responsibilities include, but are not limited to:

Appropriate delegation of study related tasks Adequate supervision of the conduct of the research PI should ensure there are standard operating

procedures for all aspects of the study specific to the research site

The PI should provide management oversight and supervision

The PI must ensure:Education, training, and expertise of investigative staffTraining measures taken when nonconformities are identifiedOngoing training efforts and study-specific trainingPersonnel involvement and impact on compliance

External facility◦ Outside

laboratories Internal facility

◦ Equipment ◦ Space

Systems to control Investigational products (IP) including the areas of:

Receiving Storing and security measures/ access controls Dispensing Overall accountability Use Return Reconciliation Process for approving personnel

Adverse event reporting Medical oversight

◦ Physician involvement in (inclusion/exclusion)

◦ Appropriate or over delegation Laboratory and specialty testing Human research subject safety/

ethics◦ IRB approval for all changes made to

protocol Protocol deviation management

The PI must ensure:Data collection, including source documentation and integrity and investigator data management processRegulatory documents are present and organizedControl to ensure security and confidentiality of the recordsDelegation of Authority and training records (to verify record/data accuracy )Documentation of training for research team

Internal quality assurance and quality control Monitoring process Internal assessment capabilities

May see more request for documentation of PI involvement◦ Training records ◦ Meetings documentation◦ E-mail correspondence

Audits will not review every subject record◦ Research team will be responsible for finding

additional issues and correcting based on instructions for the auditors

QUESTIONS