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Research Practitioner
Click on article title to view & purchase. Articles are sorted by their publication date in reverse chronological order.
Quality improvement: when is it research that requires informed consen...
March 01, 2008
Patient autonomy and complex decision making.
March 01, 2008
Competition challenges U.S. site profitability.(ISSUES IN RESEARCH MAN...
March 01, 2008
FDA seeks advisory committee consumer representatives.(Regulatory Upda...
March 01, 2008
FDA final guidance on bioresearch review and inspections of medical de...
March 01, 2008
FDA draft guidance on distributing articles about unapproved drug/devi...
March 01, 2008
FDA draft guidance on developing drugs for ABOM.(Regulatory Update)
March 01, 2008
FDA/IDSA community-acquired pneumonia workshop transcript.(Regulatory ...
March 01, 2008
FDA's clinical trials transformation initiative.(Regulatory Update)
March 01, 2008
Exam for continuing education.
March 01, 2008
New government docket and document access site announced.(Regulatory U...
March 01, 2008
Public workshop on hemoglobin-based oxygen carriers.(Regulatory Update...
March 01, 2008
OHRP Spanish pamphlet now available.(Regulatory Update)
March 01, 2008
Device investigation warning letter shows unusual deficiencies.(Regula...
March 01, 2008
Spotting duplicate reporting.(In the News)
March 01, 2008
Comments on oversight of genetic testing sought.(Regulatory Update)
January 01, 2008
Expanded protections for vaccine manufacturers.(Regulatory Update)
January 01, 2008
FDA workshop on pandemic influenza vaccine development.(Regulatory Upd...
January 01, 2008
FDA issues several new final guidance documents.(Regulatory Update)
January 01, 2008
Premarket clinical evaluation of drug-induced liver injury.(Regulatory...
January 01, 2008
FDA advisory committee draft guidance documents issued.(Regulatory Upd...
January 01, 2008
FDA issues several new treatment draft guidance documents.(Regulatory ...
January 01, 2008
Improving the quality of clinical research: recognizing issues in trai...
January 01, 2008
Informed consent in clinical trials: from process to paper.
January 01, 2008
Regulatory and ethical issues in conducting gene therapy research.
January 01, 2008
Medical professionalism.(In the News)
January 01, 2008
The evolving declaration.(In the News)
January 01, 2008
FDA draft guidance for bioequivalence studies.(Regulatory Update)(Food...
January 01, 2008
FDA draft guidance for IVD device studies.(Regulatory Update)(Food and...
January 01, 2008
Changes requested to IRB expedited review list.(Regulatory Update)(ins...
January 01, 2008
NIH policy and database on genome-wide association studies announced.(...
November 01, 2007
FDA creates docket to receive pandemic flu vaccine information.(Regula...
November 01, 2007
FDA issues companion to pharmacogenomic data guidance.(Regulatory Upda...
November 01, 2007
Final guidance on toxicity grading.(Regulatory Update)
November 01, 2007
OHRP seeks comments on decisionally impaired adults in research.(Regul...
November 01, 2007
Describing the role of the clinical research nurse.(Survey)
November 01, 2007
Pharmacogenomics and the evolving regulatory paradigm.
November 01, 2007
Payments to research subjects: ethical issues.
November 01, 2007
Medical school relationships with industry.(In the News)
November 01, 2007
Payments to research subjects: ethical issues.(Exam for Continuing Edu...
November 01, 2007
FDA pilot program for electronic preclinical data submissions.(Regulat...
November 01, 2007
FDA workshop on cellular/tissue scaffolding.(Regulatory Update)
November 01, 2007
New regulations for dietary supplements.(In the News)
July 01, 2007
The Supreme Court and medical devices.(In the News)
July 01, 2007
Ball of confusion: how stem cells have stymied review boards.
July 01, 2007
Supervisory responsibilities of investigators.
July 01, 2007
FDA releases final guidance on computerized systems used in clinical t...
July 01, 2007
FDA releases final guidance on pandemic influenza vaccine.(Regulatory ...
July 01, 2007
FDA releases final guidance on seasonal inactivated influenza vaccine....
July 01, 2007
FDA releases final guidance on clinical trial endpoints for cancer dru...
July 01, 2007
FDA draft guidance on developing drugs and biologics for malaria.(Regu...
July 01, 2007
FDA public workshop on anthrax vaccines.(Regulatory Update)
July 01, 2007
Sponsor-investigator FDA warning letter.(Regulatory Update)
July 01, 2007
How to critically review and appraise published clinical literature.
July 01, 2007
FDA solicits members for new risk communication advisory committee.
July 01, 2007
NIH proposed rule to permit multiple principal investigators.
July 01, 2007
Priority list of drugs for pediatric research.(Regulatory Update)
May 01, 2007
FDA issues draft guidance on advisory committee member conflicts.(Regu...
May 01, 2007
FDA and NCI memoranda of understanding.(Regulatory Update)
May 01, 2007
FDA releases final guidance on studies of steroids in children.(Regula...
May 01, 2007
FDA proposes e-CRF in XML pilot project.(Regulatory Update)
May 01, 2007
FDA solicits nominations for members on advisory committees.(Regulator...
May 01, 2007
Caregiver vs. scientist: the sometimes conflicting roles between the d...
May 01, 2007
Ethical issues with health care research in developing countries.
May 01, 2007
'Natural' remedies and clinical trials.(In the News)
May 01, 2007
Perspectives on informed consent in developing countries.(In the News)
May 01, 2007
Physicians and drug companies.(In the News)
May 01, 2007
Changing investigator meeting formats.(ISSUES IN RESEARCH MANAGEMENT)
May 01, 2007
FDA releases final guidance on statistics and IVD study results.(Regul...
May 01, 2007
RAC guidance on lentiviral vectors.(Recombinant DNA Advisory Committee...
May 01, 2007
SACGHS requests comments on draft pharmacogenomics report.(Secretary's...
May 01, 2007
FDA issues draft guidance on adverse event reporting.(Regulatory Updat...
May 01, 2007
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