The resources listed below cover establishment and assessment of research site quality. Resources provide informaiton on how to create internal quality assessment programs, FDA auditing, and patient safety, among other topics. These resources also feature the ASCO Research Program Quality Assessment Tool. This list is not exhaustive and will be updated periodically. If you have suggestions, please email the Research Community Forum.

I. Data Integrity
II. Internal Quality Assurance Program Protocol and Compliance
III. External Auditing of Clinical Trials
IV. Quality Improvement
V. Assuring Patient Safety
VI. Preparing for an FDA Audit
VII. Making a Hand Written Error Correction


I. Data Integrity

(Accuracy, completeness, legibility, timeliness, etc.)

II. Internal Quality Assurance Program Protocol and Compliance

(Internal quality assurance protocols, procedures, and compliance; minimum quality standards; periodic operational checks and audits of protocol data collection, handling, and processing; periodic internal quality control checks and audits of entire program)

III. External Auditing of Clinical Trials

(Sponsor audits: monitoring, inspections, requirements, policies, and procedures, documentation; FDA audits - requirements, policies, and procedures, documentation)

IV. Quality Improvement

V. Assuring Patient Safety

VI. Preparing for an FDA Audit

VII. Making a Hand Written Error Correction