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Question: According to 21 CFR 812, how long does an investigator or sponsor need to maintain the required records?

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Office for Human Research Protection (OHRP)

A federal government agency within the Department of Health and Human Services (DHHS) charged with the protection of human subjects participating in government funded research. It issues assurances and oversees compliance of regulatory guidelines by research institutions.

Welcome to GCP HelpDesk Website 

In this website you will find Good Clinical Practice (GCP) related information for the Clinical Research Industry professionals on request. The GCP HelpDesk is designed to provide information for clinical research professionals with questions regarding handling, conducting and managing clinical research as per GCP, FDA and other Regulations.  This HelpDesk is aimed to provide transparency from resources and expertise in the field of Clinical Research with the recent developments and changes in the guidelines for clinical research professionals. The GCP HelpDesk is a searchable website that will match the question with solution by industry experts and other dedicated sites to a specific area. Both simple and complicated questions are welcomed by the GCP HelpDesk   and we will provide you the answer, if not hope to point you to the one who can. The GCP HelpDesk service is completely free and you can search for required information or by sending an email to GCP Help Desk by including your full name, email address, valid phone number, and a brief description of the problem. We will get back to you through email.

Feedback
Due to the nature of the clinical research industry and we understand that there is always scope to learn more and improve and we request you to provide your feedback on the design, suggested features or problems and errors you might discover to our team at Feedback  page and we appreciate your suggestion and comments.
 

Clinical Research Today

FDA approves Xtoro to treat swimmer’s ear

The U.S. Food and Drug Administration approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear.

Acute otitis externa is an infection in the outer ear and ear canal, usually caused by bacteria ...

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CFDA issues the Third Supplements to Chinese Pharmacopeia (2010 edition)

China Food and Drug Administration (CFDA) recently issued an announcement on the implementation of the Third Supplements to Chinese Pharmacopeia (2010 edition). The Third Supplements to Chinese Pharmacopeia (2010 edition) will go into force as of February 1, 2015. The Third ...

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FDA approves first pathogen reduction system to treat plasma

The U.S. Food and Drug Administration approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI).

“The approval of ...

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FDA allows marketing of the first newborn screening test to help detect Severe Combined Immunodeficiency

The U.S. Food and Drug Administration allowed marketing of the EnLite Neonatal TREC Kit, the first screening test permitted to be marketed by FDA for Severe Combined Immunodeficiency (SCID) in newborns.

According to the Centers for Disease ...

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FDA expands approved use of Cyramza to treat aggressive non-small cell lung cancer

The U.S. Food and Drug Administration expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC).

The most common type of lung cancer, NSCLC occurs when cancer cells form in the tissues of the ...

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FDA approves first test to confirm the presence of Human T-cell Lymphotropic Virus-I/II antibodies

The U.S. Food and Drug Administration approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II). This test is intended for use as an additional, more specific test for human serum or plasma specimens that ...

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FDA resolves criminal and civil actions against Main Street Family Pharmacy

Main Street Family Pharmacy, LLC, a compounding pharmacy in Newbern, Tennessee, and the company’s co-owner, David A. Newbaker, each pleaded guilty in the United States District Court for the Western District of Tennessee to one misdemeanor criminal violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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FDA takes enforcement action against Michigan sandwich company

The U.S. Food and Drug Administration, in a complaint filed by the Department of Justice, is seeking to stop Scotty’s Incorporated, of Detroit, Michigan, which does business as Bruce Enterprises and Bruce’s Fresh Products, and Sandra J. Jackson, the firm’s co-owner and ...

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First vaccine approved by FDA to prevent serogroup B Meningococcal disease

The U.S. Food and Drug Administration announced the approval of Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

Meningococcal disease is ...

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Mixing Medications and Dietary Supplements Can Endanger Your Health

When you take prescription or over-the-counter (OTC) medications, do you take also a vitamin, mineral, or other dietary supplements? Have you considered whether there is any danger in mixing medications and dietary supplements?

There could be, says Robert Mozersky, a medical officer at ...

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FDA approves new treatment for rare form of hemophilia

The U.S. Food and Drug Administration approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVIII] deficiency).

Acquired hemophilia A is a rare, but potentially life threatening, bleeding disorder ...

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Opinion Poll

According to GCP, how should investigator show that he/she has the appropriate qualifications and experience to do the study?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.

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