Common Findings

The following ten areas are routinely examined during our routine on-site review and investigator self-assessments:

Regulatory Documentation

IRB Documentation

Subject Recruitment

Informed Consent Process

Subject Selection

Adverse Event Reporting

Drug/Device Dispensing/Accountability

Source Documentation/Case Report Form (CRF)

Recordkeeping

Allocation of Responsibilities

Between May 2004 and December 2004, Monitoring and Oversight conducted routine on-site reviews.  Each study site was assessed for its compliance with regulations and institutional policies.  Monitoring and Oversight provided corrective actions when violations were identified. 

Most problematic areas:

Regulatory Documents/Binder/Submissions	23%
Informed Consent/Assent/HIPAA	37%
Source Documentation	23%
Protocol Adherence	17%