CLINICAL RESEARCH

KEYS TO BUILDING A SUCCESSFUL RESEARCH SITE

(via Duke Clinical Research Institute)

 

TRAINING PROGRAMS: PROTECTION OF HUMAN SUBJECTS

FEDERAL REGULATIONS / POLICIES GOVERNING CLINICAL RESEARCH

SIGNING THE FDA 1572 FORM: WHAT ARE YOUR COMMITMENTS?

MUOT GUIDE TO CLINICAL TRIALS

MUOT IRB HANDBOOK

FREQUENTLY ASKED QUESTIONS REGARDING CLINICAL TRIALS AT MUOT

FREQUENTLY ASKED QUESTIONS REGARDING PROTECTION OF HUMAN RESEARCH SUBJECTS

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[LINKS MARKED AVAILABLE ONLY TO MUOT USERS]

INFORMATION FOR POTENTIAL STUDY SUBJECTS

Should I Enter a Clinical Trial? (Q & A)

DHHS, FDA, NIH LOCATOR (via Applied Clinical Trials)

INFORMED CONSENT: GUIDANCE FOR DRAFTING FORMS

FDA: CLINICAL RESEARCH INFORMATION

FDA Information Sheets

FDA Contacts for Clinical Trials

Human Subjects Protection Information

Good Clinical Practices (GCP) in FDA-Regulated Clinical Trials

 

HUMAN GENE TRANSFER PROTOCOLS

Clinical Gene Transfer Protocol Development (via Am. Soc. Gene Therapy)

Points to Consider When Planning a Genetic Study That Involves Members of Named Populations (via NIH)

 

RESEARCH LAWSUITS & SETTLEMENTS

Research Lawsuits and Settlements (via Research Roundtable)

Medical Research and Human Experimentation Law (via LSU School of Law)

Clinical Trials Litigation (via Sherman, Silverstein, Kohl, Rose and Podolsky, Law Offices)

AMA ETHICAL GUIDELINES REGARDING CLINICAL RESEARCH

ETHICAL CONDUCT OF RESEARCH INVOLVING HUMAN SUBJECTS (via Canadian Institutes of Health Research)

ClinicalTrials.gov [Internet-based Registry of Clinical Trials for Serious Illnesses] [via NIH]

Clinical Trials and Insurance Coverage: A Resource Guide (via NCI)

 

NIH CLINICAL GRANT PROPOSALS

NIH Clinical Grants Checklist - What You Need to Know (via NIAID)

Guide to Requirements for NIH Research Grants Including Human Subjects (via NIAID)

Clinical Grants Checklist By Policy (via NIAID)

Generic Monitoring Plan for Trials Requiring A Data Safety Monitoring Board (DSMB) (via NIAMS)

File Requires Adobe Acrobat ReaderNIAID Clinical Terms of Award (10/1/2002)

File Requires Adobe Acrobat ReaderGuidance for Compliance with NIAID Clinical Terms of Award (10/1/2002)

 

MUOT-SPECIFIC INFORMATION

File Requires Adobe Acrobat Reader MUOT Policy on Scope of Faculty-Physician Employment Regarding Patient-Oriented Clinical Research (Policy # 02-005)

File Requires Adobe Acrobat Reader MUOT Policy on Human Research Subjects (Policy # 02-001)

File Requires Adobe Acrobat ReaderIncentives Paid by Sponsors of Clinical Trials

File Requires Adobe Acrobat ReaderRequired Departmental of Human Research Protocols PRIOR to IRB Submission

File Requires Adobe Acrobat ReaderPersonnel on MUOT IRB Application: Decision-Support Chart

File Requires Adobe Acrobat ReaderInvestigator Responsibilities in Research Involving Human Subjects

MUOT Policy on Payment for Injury to Study Subjects

MUOT Policy on Recruitment of Study Subjects

MUOT Clinical Research Pledge

Charges for MUOT IRB Review

MUOT IRB Deadlines & Meeting Schedule

MUOT IRB Forms

Events Which Necessitate Immediately Contacting Research & Grants Admin.

MUOT Guidelines and Information for Research Involving Human Subjects

MUOT Checklist for Clinical Trial Participants

Discounted Research Patient-Care Costs

 

MEDICARE REGULATIONS REGARDING CLINICAL TRIALS

 

ITEMS OF GENERAL INTEREST

NIH Primer: Research and Privacy

Bottom Line, Culture Clash Impeding Cooperation of Managed-Care Organizations in Clinical Trials (The Scientist, June 24, 1996)

Outcomes-Based Research Resources

Internet Autopsy Database (Johns Hopkins)


INCLUSION OF WOMEN, MINORITIES, AND CHILDREN AS SUBJECTS IN CLINICAL RESEARCH

NIH Office of Research On Women's Health

Inclusion of Women Participants in Clinical Research

NIH Guidelines on the Inclusion of Women and Minorities as Study Subjects in Clinical Research (NIH Guide, Mar. 18, 1994)

Inclusion of Children Policy Implementation (via NIH Office of Extramural Research)

Decision Tree For Participation of Children (via NIH)

FAQ: Children as Research Participants (via NIH)

 

CANCER RESEARCH

NCI Policy for Data and Safety Monitoring of Clinical Trials ( via NCI)

Cancer Clinical Trials (via NCI)

NCI Surveillance, Epidemiology and End Results (SEER)

NCI CancerNet


CENTRALIZED CLINICAL TRIALS OFFICES AT OTHER INSTITUTIONS

Center for Clinical Studies (Wash. U., St. Louis)

 

GENERAL


Center Watch (International Listing of Clinical Trials)

A Manual for Participants in Clinical Trials of Investigational Agents Sponsored by DCTD, NCI (via NIH)



Page Updated: 7/21/2004

Problems with or questions concerning this page should be reported to MUOT Research & Grants Administration
research@meduohio.edu