Quality of Life Questionnaires

Factors affecting the variability of the QOL questionnaire assessment:

• Not completed in the correct sequence
• Administered after specific test procedures (i.e. treadmill testing) that impact answers
• Administrator over-interpreting questions instead of asking questions as written
• Allowing family members to answer questions for the subject or influence subject’s answers
• Not completing all questions or marking multiple answers to the same question
• Administrator not completing adequate review of questionnaires

These, and other factors effecting variability, can be controlled in a clinical research setting with thorough training and oversight.

• Site Endpoint Evaluation Visit, which includes: 1) assessment of the sites’ techniques for appropriateness for the protocol, 2) Assessment of the situation in which the test is administered, 3) Evaluation of the techniques utilized by each staff member at the site that will administer these questionnaires, 4) Review of source document and completed questionnaires to evaluate the site’s adherence to the protocol and CPC’s data collection guidelines, and 5) A detailed report to the site as well as the Sponsor noting all issues at their site and specific recommendations for improving the consistency of the assessments
• A reference tool for sites to utilize during QOL questionnaire assessment
• Thorough overview and training of the site staff during an Investigator Meeting
• Development of source documents specific to QOL assessment
• Weekly review at Endpoint Evaluation Committee meetings of issues identified during SEEVs; recommendations for corrective actions are forthcoming from this meeting
• Receiving phone calls or other inquiries from sites about data collection methods
• Sponsor Training on QOL assessments

CPC offers quality assurance of QOL assessments as described as well as quality assurance for other endpoints utilized in clinical trials. For more information on these services, please Contact Us or call 303.860.9900.