Professional Diploma in Clinical Research

Here is the link for those who want to take up a course in Clinical Research offered by Catalyst Clinical Services through distance learning.

 http://www.catalystclinicalservices.com/documents/information%20brochure.pdf

FDA ESG (Electronic Submission Gateway)

The FDA ESG is the central transmission point for sending information electronically to the FDA. The  FDA ESG is a conduit, or "highway", along which submissions travel to reach their final destination. It does not open or review submissions; it merely routes them to the proper destination. A single point of entry for receiving and processing all electronic submissions in a highly secure environment.Automating current electronic processes such as the electronic acknowledgment of submissions.Supporting the electronic Common Technical Document (eCTD).

The electronic submission process is defined as the receipt, acknowledgment, routing, and notification to a receiving Center of the receipt of an electronic submission. Each of these terms denotes a step in the process of electronic submission delivery, and together, these steps comprise the whole scope of electronic submission delivery.

"Receipt" means transfer of a submission from a sender’s system to a temporary storage area in the FDA ESG."Acknowledgment" to the sender that the submission was sent from the sender’s system and received by the Gateway."Routing" refers to delivering a submission to a Center-level storage area and initiating a load process to place a submission into a Center receiving system."Notification" of a submission’s arrival is made to those individuals responsible for the Center’s receiving system.

Differences between PSUR and PADER

Preapproval reports include IND Annual Reports in the U.S. and Annual Safety Reports (ASRs) in Europe. Some of these documents may provide cumulative information, while others contain aggregate information specific to the reporting period. Postapproval cumulative reports of safety include NDA Periodic Adverse Drug Experiences Reports (PADERs) in the U.S. and Periodic Safety Update Reports (PSURs) in many other countries, including in Europe. Their purpose is to update and evaluate the worldwide safety experience with a medicine at defined time points after approval.

These reports provide succinct summary information together with an evaluation of the benefit-risk
profile of approved medicines in the light of new or changing postapproval information.This evaluation is designed to help ascertain whether further investigations need to be carried out and whether changes should be made to the approval and/or to the medicine’s labeling.

In summary, the aim of cumulative reports of safety is to:
• Report all the relevant new information from appropriate sources.
• Relate these data to patient exposure to the medicine.
•  Summarize the medicine’s approval status in different countries and any significant variations  related to safety.
• Create periodically the opportunity for an overall reevaluation of safety.
• Indicate whether changes should be made to an approved medicine’s label in order to optimize the use of the product.

Common Terminology for Adverse Events (CTCAE)- National Cancer Institute

Grading adverse events : By this grading scale, all adverse events are classified as follows:

0=No adverse event or within normal limits
1=Mild adverse event
2=Moderate adverse event
3=Severe and undesirable adverse event
4=Life-threatening or disabling adverse event
5=Death related to adverse event

Adverse Drug Reactions Classifcations: Based on Severity

a)Mild : No antidote or treatment is required; hospitalization is not prolonged

b)Moderate: A change in treatment (e.g., modified dosage, addition of a drug), but not necessarily discontinuation of the drug, is required; hospitalization may be prolonged, or specific treatment may be required

c)Severe: An ADR is potentially life threatening and requires discontinuation of the drug and specific treatment of the ADR

d)Lethal : An ADR directly or indirectly contributes to a patient's death

 

 

 

 

 

Adverse Drug Reactions Classifcations

Classification based on frequency :


a)Very common
 > 1/10 ( > 10%)
b)Common (frequent)
 > 1/100 and < 1/10 ( > 1% and < 10%)
c)Uncommon (infrequent)
 > 1/1,000 and < 1/100 ( > 0.1% and < 1 %)
d)Rare
 > 1/10,000 and < 1,000 ( > 0.01% and < 0.1%)
e)Very rare
 < 1/10,000 (< 0.01%)