1. Burke LB. Measuring treatment benefit: clinical trial outcome assessments in the evaluation of medical products. 2011. http://www.c-path.org/wp-content/uploads/2013/09/consensussciencepatientreportedoutcomesinstrumentsastools.pdf . Accessed 12 Feb 2014.
2. Walton MK. Clinical trial outcome assessments: identifying intrinsic characteristics. 2011. http://www.fda.gov/downloads/Drugs/NewsEvents/UCM277124.pdf . Accessed 15 Jan 2014.
3. US Department of Health and Human Services. Code of federal regulations title 21, subchapter D—drugs for human use, part 314—applications for FDA approval to market a new drug, subpart D—FDA action on applications and abbreviated applications, section 314.126—adequate and well-controlled studies. 2010. http://www.gpo.gov/fdsys/pkg/CFR-2010-title21-vol5/pdf/CFR-2010-title21-vol5-sec314-126.pdf . Accessed 10 Feb 2014.
4. US Food and Drug Administration. Clinical outcome assessment qualification program. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm284077.htm . Accessed 10 Feb 2014.
5. US Food and Drug Administration. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. 2009. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf . Accessed 14 Jan 2014.