QC2 Publications and Resources

 

QC2 Publications

Good Clinical Practice: A Question & Answer Reference Guide 2013

Mardesich, M Joseph, contributing author to: Hamrell, Michael. (2012). Good Clinical Practice: A Question & Answer Reference Guide.  M. Hamrell & M.P. Mathieu (Eds).  Massachusetts: Parexel.

Institutional Review Board Safety Reporting Policies: Are Changes for the Better?

Lieck, D. (2007).  Institutional Review Board Safety Reporting Policies: Are Changes for the Better? Journal of Clinical Research Best Practices, 3(2).

EDC Systems-A Seamless Transition

Mardesich, M Joseph. (2004, July).  EDC Systems-A Seamless Transition.  DIA Forum, 14-15.

Drug Accountability at the Investigative Site

Lieck, D., & Bertram, J. (2002). Drug accountability at the investigative site. Applied Clinical Trials, 11(3), 36-44.

 

QC2 Resources

Clinical Outcomes Assessment Resources – including PROs, ClinROs, and ObsROs

Below are QC2 resources related to Clinical Outcomes Assessment.  Learn more about developing, revising, administering, and interpreting PROs, ClinROs, and ObsROs.  Quality and Compliance Consulting offers customized consulting services in the area of clinical outcomes assessment. If you have any questions or need additional information regarding PRO development, revision, administration, or other related issues, please feel free to contact QC2 at qc2@qc2.com.

Developing a New PRO Summary

This document provides a brief summary of the 2009 “Use of Existing Patient-Reported Outcome (PRO) Instruments and Their Modification: The ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report”.  Learn about recommendations for PRO development and revision including: 1) Conceptualization; 2) Information Gathering; 3) Data Collection; and 4) Integration, Revision, and Finalization.