0A4F4F9BD490A749D5437F821CF06DF1
Good Clinical Practice and Human Subject Protections in FDA-Regulated Clinical Trials
https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection
http://leaux.net/URLS/ConvertAPI Text Files/9A586E6144E97521152D0067CB3E15C1.en.txt
Examining the file media/Synopses/9A586E6144E97521152D0067CB3E15C1.html:
This file was generated: 2020-07-14 04:46:00
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Health / Drug Usage
Searching for indicator drug:
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p.(None): Search Menu
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): IN THIS SECTION
p.(None):
p.(None): Science and Research Special
p.(None): Topics
p.(None):
p.(None):
p.(None):
p.(None): Clinical Trials and Human Subject Protection
p.(None): Subscribe to Email Updates Share Tweet Email
p.(None):
p.(None):
p.(None):
p.(None): Adherence to the principles of good clinical practice (GCP), including human subject protection (HSP), is universally recognized as
p.(None): a critical requirement to the ethical conduct of research involving human subjects. The Food and Drug Administration (FDA)
p.(None): regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP. FDA
p.(None): regulations and guidance documents, and international GCP guidance documents on which FDA has collaborated, and that have
p.(None): been adopted as official FDA guidance, are also found here.
p.(None):
p.(None):
p.(None): Office of Good Clinical Practice
p.(None): The Office of Good Clinical Practice (OGCP) serves as the FDA focal point for GCP and HSP issues related to FDA-regulated
p.(None): clinical trials. OGCP sets priorities for the development of GCP and HSP policy, works to ensure consistency in GCP and HSP
p.(None): policy across the agency, participates in international GCP and HSP harmonization activities, and serves as liaison to other Federal
p.(None): agencies and external stakeholders committed to the protection of human research participants. (For more information, see
p.(None): OGCP's mission statement.)
p.(None):
p.(None):
p.(None): In The News
p.(None): FDA Reopens the Comment Period for the Proposed Rule Regarding IRB Waiver or Alteration of Informed Consent for
p.(None): Minimal Risk Clinical Investigations (February 2019)
p.(None):
p.(None): FDA Extends the Comment Period for the Proposed Rule Regarding IRB Waiver or Alteration of Informed Consent for Minimal
p.(None): Risk Clinical Investigations (December 2018)
p.(None): Proposed Rule: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
...
Searching for indicator foia:
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p.(None): support research and marketing applications/submissions to the agency. Links to the compliance programs for each inspection
p.(None): type and contact information for each Center’s BIMO program are also accessible from this site.
p.(None):
p.(None):
p.(None): Workshops, Meetings, and Conferences
p.(None): Conferences
p.(None):
p.(None): Workshops and Meetings
p.(None):
p.(None):
p.(None): Contacts
p.(None): Good Clinical Practice Contacts
p.(None): IND/IDE Contacts
p.(None):
p.(None): Bioresearch Monitoring Program Contacts (FDA Centers)
p.(None): How to Report Complaints or Problems About Clinical Trials to FDA
p.(None): Resources For You
p.(None): Clinical Trial Forms
p.(None): ClinicalTrials.gov (NIH)
p.(None):
p.(None): FDA Basics
p.(None): FDA Basics for Industry
p.(None): Laws Enforced by FDA
p.(None):
p.(None): Freedom of Information
p.(None): Dockets Management
p.(None):
p.(None): Approvals of FDA-Regulated Products
p.(None):
p.(None): Websites with Information About Clinical Trials
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Content current as of:
p.(None): 04/22/2019
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Subscribe
p.(None): Sign up for Good Clinical Practice/Human Subject Protection e-mail updates
p.(None):
p.(None): Email Address Subscribe
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): FDA Archive
p.(None):
p.(None): About FDA
p.(None):
p.(None): Accessibility
p.(None):
p.(None): Visitor Information
p.(None):
p.(None): Website Policies / Privacy
p.(None):
p.(None): No FEAR Act
p.(None):
p.(None): FOIA
p.(None):
p.(None): HHS.gov
p.(None):
p.(None): USA.gov
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Contact FDA
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 1-888-INFO-FDA (1-888-463-6332)
...
Searching for indicator freedomXofXinformation:
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p.(None): Risk Clinical Investigations (December 2018)
p.(None): Proposed Rule: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
p.(None): (November 15, 2018)
p.(None): Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations: Guidance for Sponsors,
p.(None): Investigators, and Institutional Review Boards (October 2018)
p.(None): Good Clinical Practice: Previous "In the News" Items
p.(None):
p.(None):
p.(None): Bioresearch Monitoring
p.(None): FDA’s bioresearch monitoring (BIMO) program conducts on-site inspections of both clinical and nonclinical studies performed to
p.(None): support research and marketing applications/submissions to the agency. Links to the compliance programs for each inspection
p.(None): type and contact information for each Center’s BIMO program are also accessible from this site.
p.(None):
p.(None):
p.(None): Workshops, Meetings, and Conferences
p.(None): Conferences
p.(None):
p.(None): Workshops and Meetings
p.(None):
p.(None):
p.(None): Contacts
p.(None): Good Clinical Practice Contacts
p.(None): IND/IDE Contacts
p.(None):
p.(None): Bioresearch Monitoring Program Contacts (FDA Centers)
p.(None): How to Report Complaints or Problems About Clinical Trials to FDA
p.(None): Resources For You
p.(None): Clinical Trial Forms
p.(None): ClinicalTrials.gov (NIH)
p.(None):
p.(None): FDA Basics
p.(None): FDA Basics for Industry
p.(None): Laws Enforced by FDA
p.(None):
p.(None): Freedom of Information
p.(None): Dockets Management
p.(None):
p.(None): Approvals of FDA-Regulated Products
p.(None):
p.(None): Websites with Information About Clinical Trials
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Content current as of:
p.(None): 04/22/2019
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Subscribe
p.(None): Sign up for Good Clinical Practice/Human Subject Protection e-mail updates
p.(None):
p.(None): Email Address Subscribe
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): FDA Archive
p.(None):
p.(None): About FDA
p.(None):
p.(None): Accessibility
p.(None):
p.(None): Visitor Information
p.(None):
p.(None): Website Policies / Privacy
p.(None):
p.(None): No FEAR Act
p.(None):
p.(None): FOIA
p.(None):
p.(None): HHS.gov
p.(None):
p.(None): USA.gov
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Contact FDA
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 1-888-INFO-FDA (1-888-463-6332)
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| drug | Drug Usage |
| foia | Access to information |
| freedomXofXinformation | Access to information |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| foia | ['freedomXofXinformation'] |
| freedomXofXinformation | ['foia'] |
Trigger Words
consent
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input