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Question: What are the factors to trigger a Study-oriented audit at investigator site by the regulatory bodies?

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Dose - ranging study
A clinical trial in which two or more doses of an agent (e.g., a drug) are tested against each other to determine which dose works best and is least harmful.
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.

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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 releases updated proposals to improve food safety and help prevent foodborne illness in response to public comments

Based on extensive outreach and public comment, the U.S. Food and Drug Administration proposed revisions to four proposed rules designed to help prevent food-borne illness. When finalized, the proposed rules will implement portions of the FDA Food Safety Modernization Act (FSMA), which aims ...

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FDA approves Trulicity to treat type 2 diabetes

The U.S. Food and Drug Administration approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.

Type 2 diabetes affects about 26 million people and accounts for ...

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Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations

The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products licensed by FDA under the Public Health Service Act (the PHS Act). The lists include the date a biological product was licensed under 351(a) of the PHS Act and ...

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FDA approves Movantik for opioid-induced constipation

The U.S. Food and Drug Administration approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.

Opioids are a class of drugs that are used to treat and manage pain. A common side effect associated with ...

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Emergency asthma inhalers for use in schools

From 1 October 2014 schools will be allowed to keep a salbutamol inhaler for use in emergencies when a child with asthma cannot access their own inhaler.

Keeping an inhaler for emergency use will have many benefits. It could prevent an ...

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Domperidone to be available only as a prescription medicine

From 4 September 2014, people taking domperidone to treat nausea and vomiting will only be able to get this medicine on prescription from their doctor. It will no longer be available from pharmacies without a prescription, the Medicines and Healthcare products Regulatory Agency (MHRA) ...

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Addendum: Good Clinical Pratice

This topic was endorsed by the ICH Steering Committee in June 2014.

Since the adoption of the ICH E6(R1) Guideline on Good Clinical Practice (GCP) in 1996, clinical trials have evolved substantially, with increases in globalisation, study complexity, and technological capabilities.  ...

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FDA approves weight-management drug Contrave

The U.S. Food and Drug Administration approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.

The drug is approved for use in adults with a ...

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FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas

The U.S. Food and Drug Administration is reminding health care professionals and consumers about safety concerns with all sterile-use drug products made and distributed by Downing Labs LLC, doing business as NuVision Pharmacy, in Dallas, Texas. Health care professionals should not use ...

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FDA allows marketing of the first test to assess risk of developing acute kidney injury

The U.S. Food and Drug Administration allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to help determine if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following ...

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FDA approves Keytruda for advanced melanoma

The U.S. Food and Drug Administration granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.

Melanoma, which accounts for approximately 5 percent of all new cancers in the ...

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Opinion Poll

Which organizations listed below would you say has the greatest responsibility in educating the public about clinical trials?
 
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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