1. Human Resources
  2. Food & Drug
  3. Education
  4. Grants
  5. Healthcare
  6. Energy
  7. Environmental Compliance
  8. Broadband
  9. Finance
Sample product pages from Guide to Good Clinical Practice
Public ¶140 Considerations in Large-scale or International Trials
Public ¶1000 Executive Summary
Public ¶1110 FDA's Bioresearch Monitoring Program
Public ¶1130 FDA's Clinical Investigations/Bioresearch Monitoring Branches
Public ¶1200 Executive Summary
Public ¶1210 Office for Civil Rights and HIPAA
Public ¶1220 Office for Human Research Protections
Public ¶1240 Centers for Medicare and Medicaid Services
Public ¶260 FDA's Process for Disqualifying Investigators
Public ¶270 FDA Debarment
Public ¶330 Ongoing Clinical Evaluation
Public ¶400 Executive Summary
Public ¶440 FDA Forms
Public ¶600 Executive Summary
Public ¶700 Executive Summary
Public ¶800 Executive Summary
Public ¶810 FDA Requirements for IRBs
Public ¶870 Non-local IRBs
Public ¶910 European Union GCP
Public ¶950 International Conference on Harmonisation
Public ¶960 Latin America GCP
Public APHA Roundup
Public States Offer Myriad of Options for Legally Authorized Representative
Public FDA Plans New Rules on Electronic Data Submission, Falsification of Data, Protecting Decisionally Impaired
Public News Briefs
Public ATS Sets Guidelines for Research Involving Critically Ill Subjects
Public HHS Task Force Recommends Standardizing Electronic Clinical Trial Data; CBER Begins Pilot Project
Public VA Amends Adverse Event Reporting Requirements
Public Emanuel Proposes U.S. Move to Regional IRB System
Public Trade Groups Agree to Clinical Trial Disclosure; Former FDA Reviewer Calls for Release of NDA Data
Public HHS Sets Tougher COI Rules for NIH, Expands FDA 'Regulated Organization'
Public Federal False Claims Act Charges For Gene Therapy Study Settled
Public FDA Needs More Time To Study Pediatric Device Needs
Public State Bills Address Clinical Trial Registry Provisions
Public News Briefs
Public More Agency, Industry Work Needed Before SDTM Improves FDA Review Time and Quality
Public News Briefs
Public ACRP Proposes Clinical Trial Registry Tied to Comprehensive Adverse Event Reporting System
Public Proposed Pediatric Changes Could Mean More Federal Protocol Reviews
Public Trial Registries, Result Databases May Have Unintended Consequences
Public Federal Prosecutor Sees "Coming Storm" for Trials
Public News Briefs
Public States Continue To Consider Trial Registration, Result Disclosure
Public News Briefs
Public Whether Sponsor Is Large Company Or Individual, IND Rules Are the Same
Public News Briefs
Public News Briefs
Public FDA Expects ClinicalTrials.gov Listings To Increase
Public Do the Best You Can, Federal Officials Tell IRBs, Investigators and Sponsors Affected by Hurricanes
Public Making Clinical Trial Agreements Stand Up to Close Scrutiny Following Consulting Revelations
Public FDA Guidance
Public Written Request Still Needed for Pediatric Exclusivity for PREA Studies, FDA Says
Public OMB Categories Urged for Race, Ethnicity Data
Public Federal Agencies Should Adopt Subpart D: IOM
Public Court Watch
Public Most AEs Do Not Need To Be Reported to OHRP
Public How To Handle External Adverse Event Reports
Public IOM Prison Research Report Expected This Spring
Public VA Details Requirements for Reporting Human Subject Protection Problems and Misconduct
Public News Briefs
Public FDA To Revise IRB Adverse Event Reporting Process
Public HIPAA Questions Are Becoming More Case Specific
Public News Briefs
Public ClinicalTrials.gov Registration Up Dramatically; But Some Information Still Not Fully Available
Public Providers Seek Guidance on JCAHO, HIPAA Overlap
Public News Briefs
Public FDA Takes New Approach To Phase 1 Manufacturing
Public FDA Revises Data Monitoring Committee Guidance
Public Maryland Program Boosts Rural Trial Participation
Public FDA, NCI, CMS Want To Add Biomarker Qualification Effort to Planned Oncology Clinical Trials
Public Education Is Better Predictor of IC Understanding Than Race, Ethnicity and Other Factors, Study Finds
Public News Briefs
Public SACHRP Roundup
Public Lepay Details FDA Plans for Info Sheets, Guidance
Public CDRH Looks for 'Least Burdensome' Trial Approach
Public FDA Sets Requirements for Pediatric Study Review
Public FDA Looking To Extend Its Authority to Clinical Trial Subcontractors and Subinvestigators
Public FDA Examines Ways To Improve Clinical Trial Quality
Public FDA Action
Public IOM Panel Calls for Uniform Guidelines, Federal Oversight for All Research Involving Prisoners
Public OIG Blasts FDA's Handling of Postmarketing Studies
Public Expert Group Recommends Regulatory Refinements In Wake of Life-threatening Consequences of UK Trial
Public News Briefs
Public Sponsors, Investigators, IRBs Are Unfamiliar with Consultation, Disclosure Required by IC Waiver
Public Public Comments Support CMS Trial Policy Revision
Public Spate of Congressional Bills Could Affect Trials
Public FDA Action
Public News Briefs
Public More Criminal Research Misconduct Cases Expected
Public What Catches a Prosecutor's Interest in Research Misconduct?
Public Researchers Call for National Advisory Board To Examine Informed Consent Waiver Issues
Public Consultation Should Be Based on Risk, FDA Told
Public News Briefs
Public FDA Still Recommends 'Minimum' 15-year Follow-up For Gene Trials Using Retroviral Vectors
Public News Briefs
Public CMS Panel Rejects Strict Criteria for Medicare Beneficiary Enrollment in Covered Clinical Trials
Public OIG: FDA Needs To Improve Oversight of Its Research
Public News Briefs
Public New York Legislator Seeks to Revamp State Human Research Subject Protection Law
Public News Briefs
Public State Roundup
Public Expanded Access May Force Clinical Trial Changes
Public SACHRP Approves Minimal Risk Interpretation
Public News Briefs
Public New Research Policy Shifts CMS Attention From Beneficiary Trial Access to Trial Regulation
Public Sponsors, Researchers and Government Examine How To Increase Minority Clinical Trial Participation
Public FDA Action
Public News Briefs
Public Senate Bill Expands ClinicalTrials.gov To Include Device Trials, Most Drug Trials and Result Links
Public State Roundup
Public FDA Continues To Wrestle with Expanded Access
Public House Cancer Caucus Chairs Introduce Bill To Provide Insurance Coverage for Cancer Trials
Public News Briefs
Public CMS Reopens Clinical Research Policy Consideration
Public FDA Action
Public News Briefs
Public Appeals Court Rules Terminally Ill Patients Have 'No Fundamental Right' to Investigational Products
Public Does Insurance Coverage Affect Trial Conduct?
Public OIG Finds FDA Centers Change High Percentage of BIMO Inspectors OAI, NAI Recommendations
Public OHRP Wants Public Say on Developing Guidance or Regs on Research Involving Decisionally Impaired
Public FDA Action
Public News Briefs
Public Trial Registration and Results Disclosure Entail More Than New FDAAA Requirements
Public Society Calls for Broad-based Program To Increase Minority Participation in Clinical Research
Public News Briefs
Public Federal Panel Wants HIPAA Requirements Extended
Public CED Coverage of Artificial Heart Trials Proposed
Public Studies on Studies
Public N.J. Legislature Considers Trial Registration
Public State Roundup
Public IOM Committee Examines Definition of Research
Public U.K. Starts Voluntary Accreditation Program for Clinical Sites Conducting Phase 1 Trials
Public EC Guidance Recommends Assent for Pediatric Trials
Public States Take Closer Look at Requiring Insurance Coverage for 'Routine' Trial Costs
Public News Briefs
Public QI Researchers Ask for Common Rule Clarification
Public Drug-eluding Stent Trials May Require Feasibility Studies, Data Monitoring Boards, FDA Recommends
Public Increasing Trials in India, China Face Challenges
Public FDA Final Rule on Acceptance of Non-IND Foreign Clinical Studies Makes Few Changes from Draft
Public Court Watch
Public State Round Up
Public Children's Study May Run into Ethics Problems
Public Studies on Studies
Public Adverse, Unexpected Event Reporting Is Complex
Public SACHRP Wants More Guidance on Roles of IOs
Public Institutional Official Responsibilities
Public FDA Expands HDE Guidance; Adds Pediatrics, IRBs
Public FDA Rejects Claims That Clinical Trial Registry Certification Does Not Apply to INDs, Other Reports
Public FDA Action
Public FDA Action
Public CMS Clarifies Payment for Routine Trial Cost; Medicare HMO Rules May Hinder Trial Participation
Public News Briefs
Public OHRP Expands Examples of Non-research Activity
Public New Director Says OHRP Needs To Be More 'User-friendly'
Public SACHRP Takes Look at Shortening Consent Forms
Public News Briefs
Public FDA, OHRP Say Data from Subjects Who Discontinue Participation in Clinical Trials Must Be Retained
Public FDA Warning Letters
Public CDRH Works on Guidance on Women in Device Trials
Public ClinicalTrials.gov Details Interpretation of 'Responsible Party' and 'Applicable Trial'
Public Data Posted on ClinicalTrials.gov Should Receive The Same Scrutiny as Data for Journal Articles
Public OHRP Issues Q&A Guidance To Clarify When Quality Improvement Activities Become Human Research
Public State Roundup
Public News Briefs
Public Suit Over Clinical Research in Nigeria Revived
Public OIG Recommends FDA Better Monitor Clinical Trial Investigators' Financial Disclosures
Public FDA Clarifies When Certification of Clinical Trial Registration Is Required for Submissions
Public AAHC Survey Still Finds HIPAA Research Problems
Public States, Congress Consider Trial Insurance Coverage
Public IOM Advocates 'New Approach' for Research Data
Public ClinicalTrials.gov Goes to Two-tier Quality Review
Public More International Trial Registries Spring Up
Public Studies on Studies
Public News Briefs
Public GAO Concludes IRB System Is 'Highly Vulnerable'
Public OHRP Asks for Comments on Making External IRBs 'Directly Responsible' for Accepted Duties
Public FDA Action
Public EC Looks to Pediatric Rules To Get Handle on Trials
Public State Round Up
Public News Briefs
Public ClinicalTrials.gov Users Reporting AEs, Agreements
Public IOM: Bar Researchers with 'Significant' Financial Conflicts from Conducting Human Trials
Public Group Calls for Federal Oversight of All U.S. Trials
Public OIG Wants More FDA Oversight of Investigators
Public Clinical Trials Have a Role in Comparative Effectiveness Research, Expert Contends
Public 'Significant' Resources Needed for Subpopulation Comparative Effectiveness Research
Public VA Provides Guidance on Pregnancy and Research
Public European Round Up
Public FDA Action
Public News Briefs
Public FDA Wants Potential Liver Problems on CRFs
Public Simplified Informed Consent Form Template Developed for Phase 1 Cancer Clinical Trials
Public NIH News
Public Studies on Studies
Public HHS Issues Interim HIPAA Breach Notification Rules
Public FDA Issues Final Rules on Charging for Investigational Drugs, Expanded Access With Few Changes
Public News Briefs
Public FDA Status of the Majority of Postmarketing Studies Inaccurate; Large Number Unreviewed
Public News Briefs
Public FDA To Revise Disqualification Regulation, Guidance
Public EC Looks To Improve Clinical Trials Directive
Public AHRQ Provides Free Tool To Aid Informed Consent
Public Former InterMune CEO Found Guilty of Wire Fraud
Public News Briefs
Public OHRP Releases Draft First Guidance on IRB Approval of Research with Conditions
Public International News
Public Research on Research
Public News Briefs
Public Policy Paper Proposes IRBs Review Conflicts of Interest for Research in Community Settings
Public News Briefs