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Question:According to EMA, What is the retention period for essential documents?

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Drug Accountability
The process of accounting for the amount of drug sent to an investigator, the amount reported as taken by study subjects, and the amount of drug returned to the sponsor at the end of a trial.
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 approves blood pump system to help patients maintain stable heart function during certain high-risk cardiac procedures

The U.S. Food and Drug Administration approved the Impella 2.5 System, a miniature blood pump system intended to help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention (HRPCI) procedures, such as balloon angioplasty and stenting, which re-open ...

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FDA approves Cholbam to treat rare bile acid synthesis disorders

The U.S. Food and Drug Administration approved Cholbam (cholic acid) capsules, the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders). Patients with ...

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MHRA is 1 of 10 regulators to help with the development of treatments for dementia

Following a workshop with other international regulators, MHRA has published information on how we continue to support the development of drugs for dementia today.

The workshop, which took place in November 2014, was used to see how ...

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FDA releases final guidance on reprocessing of reusable medical devices

The U.S. Food and Drug Administration announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses.

The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers ...

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FDA approves first therapy for high-risk neuroblastoma

The U.S. Food and Drug Administration approved Unituxin (dinutuximab) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children.

Neuroblastoma is a rare cancer that forms from immature nerve cells. ...

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FDA approves CPR devices that may increase chance of surviving cardiac arrest

On 09 Mar 2015, the U.S. Food and Drug Administration approved the ResQCPR System, a system of two devices for first responders to use while performing cardiopulmonary resuscitation (CPR) on people whose hearts stop beating (cardiac arrest). The devices may improve the ...

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FDA authorizes use of first device to treat patients with dialysis-related amyloidosis

On 06 Mar 2015, the U.S. Food and Drug Administration authorized use of Lixelle Beta 2-microglobulin Apheresis Column, the first device to treat dialysis-related amyloidosis (DRA).

Dialysis-related amyloidosis is a chronic, progressive condition caused by the buildup in the body of a ...

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FDA approves first biosimilar product Zarxio

On 06 Mar 2015, the U.S. Food and Drug Administration approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.

Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or ...

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FDA approves new antifungal drug Cresemba

On 06 Mar 2015, the U.S. Food and Drug Administration approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections.

Aspergillosis is a fungal infection caused by Aspergillus ...

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FDA expands approved use of Opdivo to treat lung cancer

The U.S. Food and Drug Administration expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

Lung cancer is the leading cause of cancer death in ...

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TGA: New ingredient names available for metal amino acid chelates

Background

Naming and characterisation ambiguities associated with metal amino acid chelates was originally discussed at the Interim Joint Expert Advisory Committee on Complementary Medicines (IJEACCM) (20-21 July 2006), as part of the Permitted Ingredients List (PIL) Project. A list of ingredients for ...

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Opinion Poll

Which one of the following do you think is the most common reason for participating in 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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