Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to SurgeryReferences
- Basics of case report form designing in clinical research.Perspectives Clinical Research. 2014; 5: 159-166
Hufford MR, Stone AA, Shiffman S, Schwartz JE, Broderick JE. Paper vs. electronic diaries: compliance and subject evaluations. 2002. Applied Clinical Trials, 38–43 Available from: http://www.appliedclinicaltrialsonline.com/.
- A randomized study of electronic diary versus paper and pencil collection of patient-reported outcomes in patients with non-small cell lung cancer.Patient. 2008; 1: 105-113
US Department of Health and Human Services; Food and Drug Administration; Center for Devices and Radiological Health; Center for Biologics Evaluation and Research. Guidance for industry and Food and Drug Administration staff—medical device data systems, medical image storage devices, and medical image communications devices. Available from: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm401996.pdf.
US Department of Health and Human Services; Food and Drug Administration. Guidance for industry—computerized systems used in clinical investigations. Available from: http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0440-gdl0002.pdf.
US Department of Health and Human Services; Food and Drug Administration. Guidance for industry—patient-reported outcome measures: use in medical product development to support labeling claims. Available from: http://www.fda.gov/downloads/Drugs/.../Guidances/UCM193282.pdf.
Clinical Data Interchange Standards Consortium. CDISC SDTM/ADaM Pilot Project. Available from: http://www.cdisc.org/cdisc-sdtm/adam-pilot-project.
Clinical Data Interchange Standards Consortium. FDA final binding guidance on standards now available. Available from: https://www.cdisc.org/FDA-Final-Binding-Guidance-on-Standards.
World Health Organization. WHO policy perspectives on medicines- pharmacovigilance: ensuring the safe use of medicines. 2004. Available from: http://apps.who.int/iris/bitstream/10665/68782/1/WHO_EDM_2004.8.pdf.
- Current trends in pharmacovigilance.J Pharmacovigil. 2012; 1: 108
- Pharmacovigilance: clinical perspectives towards patient safety.J Pharmacovigil. 2005; 3: 2
- Drug discovery and development: an insight into pharmacovigilance.J Pharmacovigil. 2014; 2: 2
- Pharmacovigilance in the new millennium: challenges, opportunities and new directions.J Pharmacovigilance. 2013; 1: e106
US Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research. Guidance for industry—good pharmacovigilance practices and pharmacoepidemiologic assessment. Guidance for industry good pharmacovigilance practices and pharmacoepidemiologic assessment. Available from: http://www.fda.gov.
International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. Efficacy guidelines—ICH guidelines: E6 good clinical practice. Available from: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html.
Center Watch. Survey of investigative sites 2007. Available from: http://www.centerwatch.com/.
- Introduction to statistical methods for clinical trials.CRC Press, Boca Raton2007
- The role of consulting units in statistics departments.American Statistician. 1987; : 260-264
International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. Efficacy guidelines—ICH guidelines: E9 statistical principles for clinical trials. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf.
International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. Efficacy guidelines—ICH guidelines: E3 structure and content of clinical study reports. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf.
- Clinical study reports of randomized controlled trials: an exploratory review of previously confidential industry reports.BMJ Open. 2013; 26: 3
International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. Mutlidisciplinary guidelines—M4: the common technical document. Available from: http://www.ich.org/products/ctd.html.
Food and Drug Administration. Guidance for industry. Part 11, electronic records; electronic signatures—scope and application. Available from: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm.
Article Info
Publication History
Footnotes
All authors (J.S.S., J.W., S.B., M.B., N.H., S.M., M.B., and E.R.), declare that they are employees of JSS Medical Research.
No direct or indirect financial support was provided to the authors for their contribution to this report.
