example_data_and_docs.md

Example Documents

Created: James Gardner, 2016-02-14
Audience: Community
Maturity: Pre-Alpha

This page is designed to help people outside the medical research field understand what the various documents we are talking about look lile.

It would be great to start collecting more/better examples of each of these areas so please let us know of any. If they aren't on this list, we don't know about them yet, so would like you to let us know.

Trial Paperwork

Summary : https://www.gsk.com/media/389560/depression_329.pdf

Protocol : http://www.gsk.com/media/360485/329-AppA.PDF

Protocol Ammendment : See pages 6-9 of 329-AppA.PDF above

Synopsis : See pages 10-11 of 329-AppA.PDF above

Patient Information Sheets : TO ADD

Consent Forms : See pages 60-64 of 329-AppA.PDF above

Case Report Forms : See pages 96-55 of 329-AppA.PDF above

Data Evaluation Plan : See pages 41-44 of 329-AppA.PDF above

Lay Summaries : TO ADD

Regulatory Documents

Clinical Study Report : http://www.gsk.com/media/389566/depression_329_full.pdf

Safety results : See pages 92-118 depression_329_full.pdf

Also:

• Drugs@FDA - https://www.accessdata.fda.gov/scripts/cder/drugsatfda/ http://www.fda.gov/Drugs/InformationOnDrugs/ucm079750.htm
• European public assessment reports - http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d125

Publications

• Abstracts only for closed sources initially?
  • PubMed http://www.ncbi.nlm.nih.gov/pubmed/26837056
• Paywall
  • e.g. http://www.scopus.com/ which I can't see at all
• Full documents for open journals? (Note, there will be a lot of non-trials ones, so we need to find the right ones)
  • BioMedCentral - https://www.biomedcentral.com/
  • Directory of open journals? https://doaj.org/
  • Elsiver Open Access (a lot of them appear empty!)
    • https://www.elsevier.com/about/open-science/open-access/open-access-journals
      • http://www.journals.elsevier.com/alzheimers-and-dementia-diagnosis-assessment-and-disease-monitoring/
  • Wiley Open Access
    • http://www.wileyopenaccess.com/view/index.html
  • BMJ
  • Lancet
  • PLOS etc

Registers

• National - https://clinicaltrials.gov/ http://www.who.int/ictrp/en/ https://www.clinicaltrialsregister.eu/
• Commercial - http://www.gsk-clinicalstudyregister.com/

Other interesting data

• Drug registers e.g. http://www.accessdata.fda.gov/scripts/cder/ndc/dsp_searchresult.cfm
• Public assessment reports - http://www.ema.europa.eu/ema/index.jsp?curl=pages/home/Home_Page.jsp
• FDA Adverse Events - http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082193.htm