Untitled Document

Links

HOME PAGES OF RELEVANT WEB SITES:
(from the GCRC RSA website at http://www.gcrconline.org/rsa/index.htm)

Association of American Medical Colleges (AAMC): http://www.aamc.org/
The Food and Drug Administration (FDA): http://www.fda.gov/
National Bioethics Advisory Commission: http://bioethics.georgetown.edu/nbac/
National Cancer Institute: http://www.nci.nih.gov/
National Center for Research Resources (NCRR): http://www.ncrr.nih.gov/
National Institutes of Health: http://www.nih.gov/
Office of Research Integrity: http://ori.dhhs.gov/
Office for Human Research Protections (OHRP): http://ohrp.osophs.dhhs.gov/
Public Responsibility in Medicine & Research (PRIMR/ARENA):
http://www.primr.org/
RSA web site: http://www.gcrconline.org/rsa/index.htm

KEY DOCUMENTS:

ADVERSE EVENTS (AE) REPORTING:

Expedited Safety Reporting Requirements for Human Drug and
Biological Products: http://www.fda.gov/cder/aers/fr07oc97.htm
NIH guidance for reporting AEs for multi-site clinical trials with a DSMB
(June 11, 1999): http://grants.nih.gov/grants/guide/notice-files/not99-107.html

AUDITS/INSPECTIONS:

FDA inspections of IRBs and clinical investigators:
http://www.fda.gov/oc/ohrt/irbs/operations.html

BIOLOGICAL SAMPLING:

NCI sample consent form for use of tissue for research:
http://www-cdp.ims.nci.nih.gov/infcondocs991.html
National Bioethics Advisory Commission Publications:
http://bioethics.georgetown.edu/nbac/pubs.html

CLINICAL TRIALS INFORMATION:

NIH/FDA/NLM joint effort to provide clinical trial information to the public:
http://clinicaltrials.gov
CenterWatch (focuses on industry supported trials):
http://centerwatch.com
COMMON TOXICITY CRITERIA (GRADING SCALE):
NCI Common Toxicity Criteria (CTC): http://ctep.cancer.gov/forms/
CTCv20_4-30-992.pdf or http://ctep.cancer.gov/reporting/ctc.html

CONFIDENTIALITY:

CONFLICT OF INTEREST:

Institutional responsibility regarding conflicting interests of investigators:
http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm

CONDUCT OF HUMAN SUBJECT RESEARCH:

Guidelines for the conduct of research involving human subjects at the NIH:
http://ohsr.od.nih.gov/guidelines.php3

DATA AND SAFETY MONITORING (e.g., DSMPs):

DATA & SAFETY MONITORING COMMITTEES (DSMCs or DSMBs):

On the Establishment and Operation of Clinical Trial Data Monitoring Committees
(draft guidance document) FDA DSMB (DMC) criteria:
http://www.fda.gov/cber/gdlns/clindatmon.htm#2
Guidelines for data and safety monitoring:
http://ohsr.od.nih.gov/info/rinfo_18.php3

HIPAA:

Office of the Secretary; Standards for Privacy of Individually Identifiable Health
Information; Proposed Rule [HIPAA; 45 CFR Parts 160 and 164]:
http://www.hhs.gov/ocr/hipaa/
Julie Kaneshiro, Ph.D., OHRP "The HIPAA Privacy Rule: Implications for Clinical Research" (Power Point File):
http://www.gcrconline.org/rsa/files.htm

INFORMED CONSENT:

MedicineNet.com (good source for description of medical terminology):
http://www.medicinenet.com/Script/Main/hp.asp

INVESTIGATIONAL DRUGS:

Investigational new drug application:
http://www.fda.gov/cder/guidance/index.htm
Conducting investigational drug trials (FDA brochures for clinical investigators):
http://www.fda.gov/cder/about/smallbiz/clinical_investigator.htm

IRBs:

PCRC Resources:

Other PGCRCs:

Human Subjects Sites:

Other Links: