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Submitted
HOW TO COLLABORATE WITH INA-RESPOND
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SEMINAR
Clinical Research in Indonesia and The Centralization of Ethics Approval
INA-RESPOND’s One-Day Seminar
WEBINAR
The First Webinar series “Updates on COVID-19 Vaccine”
The 2nd Webinar: COVID-19 Diagnosis Update, Pathogenesis and Co-Infections
The 3rd Webinar in COVID-19 Series: COVID-19 Treatment
The 4th Webinar: “Lessons learned from two years of the pandemic; are we getting closer to the finish line?”
TRAINING & WORKSHOP
GRANT PROPOSAL WRITING TRAINING & WORKSHOP SERIES
1st Series: Introduction to Grant Proposal Writing
INTERNATIONAL RESEARCH ETHICS WORKSHOPS
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CLINICAL RESEARCH PROTOCOL WRITING WORKSHOP (CRIPIK 2019)
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: E6(R1) & E6(R2) Good Clinical Practice
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US Regulations
Regulations: Good Clinical Practice and Clinical Trials
45 CFR Part 46 Protection of Human Subjects
21 CFR
Part 50 Protection of human subjects
and
part 56 Institutional Review Boards
Protection of Human Subjects; Informed Consent
(January 27, 1981)
Protection of Human Research Subjects; Standards for Institutional Review Boards for Clinical Investigations
(January 27, 1981)
Protection of Human Research Subjects; Clinical Investigations Which May Be Reviewed Through Expedited Review Procedure Set Forth in FDA Regulations
(January 27, 1981)
Protection of Human Subjects; Informed Consent; Standards for Institutional Review Boards for Clinical Investigations
(January 1981)
Federal Policy for the Protection of Human Subjects
(June 18, 1991)
FDA Policy for the Protection of Human Subjects
(June 18, 1991)
Protection of Human Subjects; Informed Consent; Proposed Rule
(September 21, 1995)
Protection of Human Subjects; Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research; Final Rules
(October 2, 1996)
Protection of Human Subjects; Informed Consent
(December 22, 1995)
Protection of Human Subjects; Informed Consent Verification; Final Rule
(November 5, 1996)
Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure
(November 9, 1998)
Additional protections for children
(66 FR 20589-600, April 24, 2001)
FDA IRB Registration Rule
(21 CFR 56.106)
IRB Continuing Review After Clinical Investigation Approval (PDF – 145KB)
-02/2012
21 CFR Part 54 Financial disclosure by Clinical Investigator
Financial Disclosures by Clinical Investigators
(63 FR 5233, February 2, 1998)
Financial Disclosures by a Clinical Investigator
(63 FR 72171-81, December 31, 1998)
21 CFR
Parts 312 (investigational New Drug Application)
and
part 314 (Application for FDA Approval to Market A New Drug)
Proposed New Drug, Antibiotic, and Biologic Drug Product Regulations
(June 9, 1983)
New Drug and Antibiotic Regulations
(February 22, 1985)
New Drug, Antibiotic, and Biologic Drug Product Regulations
(March 19, 1987)
Investigational New Drug Applications and New Drug Applications
(September 8, 1995)
Investigational New Drug Applications and New Drug Applications
(February 11, 1998)
Disqualification of a Clinical Investigator
(February 16, 1996)
Disqualification of a Clinical Investigator
(September 5, 1997)
Expedited Safety Reporting Requirements for Human Drug and Biological Products
(October 7, 1997)
Clinical Hold for products intended for life threatening conditions
(65 FR 34963-71, June 1, 2000)
Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
(September 29, 2010)
Disqualification of a Clinical Investigator
(April 30, 2012)
21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies
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