Q of the week

Question:According to Indian GCP, how long does all the study related documents need to maintain by Sponsor after completion of the clinical trial?

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Plenaxis™ is indicated for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia.

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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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Clinical Research Today

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FDA issues new draft documents related to compounding of human drugs

The U.S. Food and Drug Administration issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians.

The new ...


FDA approves Lenvima for a type of thyroid cancer

The U.S. Food and Drug Administration granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease).

The most common type of thyroid cancer, DTC is ...


New case study illustrates how MHRA and OxSonics help cancer drugs to go the extra mile

The Medicines and Healthcare products Regulatory Agency (MHRA) has helped OxSonics take a big step towards developing a revolutionary generation of ultrasound devices which aim to enhance delivery of anti-cancer drugs deep into solid tumours.

OxSonics is a relatively new company ...


FDA clears system to reduce stroke risk during stent and angioplasty procedures

The U.S. Food and Drug Administration cleared for marketing the ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS), for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries. It is the first device designed to access the carotid arteries ...


FDA approves first tissue adhesive for internal use

On 4 February 2015, the U.S. Food and Drug Administration (FDA) today approved TissuGlu, the first tissue adhesive approved for internal use.

TissuGlu is a urethane-based adhesive that a surgeon can use to connect tissue flaps made during surgery to remove excess fat and ...


FDA approves Ibrance for postmenopausal women with advanced breast cancer

On 3 February 2015, the U.S. Food and Drug Administration granted accelerated approval to Ibrance (palbociclib) to treat advanced (metastatic) breast cancer.

Breast cancer in women is the second most common type of cancer in the United States. It forms in the breast ...


FDA expands uses of Vyvanse to treat binge-eating disorder

The U.S. Food and Drug Administration expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults. The drug is the first FDA-approved medication to treat this condition.

In binge-eating disorder, patients have recurrent episodes of compulsive overeating during ...


FDA approves first generic esomeprazole

The U.S. Food and Drug Administration approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older. Esomeprazole is a proton pump inhibitor that reduces the amount ...


UK-Regulator asks those with diabetes to check insulin pumps

MHRAMedicines and Healthcare products Regulatory Agency (MHRA) is asking people with a particular insulin pump to check the clock resets to the correct time and date when they change the battery or when the power is interrupted.

A fault with ...


Diclofenac tablets now only available as a prescription medicine in UK

MHRAPeople will no longer be able to purchase diclofenac tablets, used to treat pain and inflammation, from pharmacies without a prescription from their doctor due to the small risk of heart problems the Medicines and Healthcare products Regulatory Agency (MHRA) announced ...


Opinion Poll

How does GCP require the informed consent of a trail subject to be obtained?
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.