The Nervous System – Introduction

The Nervous system:
The nervous system is conventionally divided into the Central nervous system (CNS; the brain and spinal cord) and the Peripheral nervous system (PNS; neuronal tissues outside the CNS). The motor (efferent) portion of the nervous system can be divided into two major subdivisions:
1). Autonomic Nervous System
2). Somatic Nervous System
The autonomic nervous system (ANS) is largely […]

By |March 4th, 2015|Pharmacology|0 Comments

MedDRA Dictionary overview

MedDRA Dictionary Introduction:
The Medical Dictionary for Regulatory Activities(MedDRA) is an international multilingual terminology that is applicable through all phases of the development cycle. Use of medDRA on a global basis allows standardized communication between industry and regulators regardless of country or agency. MedDRA permits the classification of a wide range of clinical information and medical […]

By |December 13th, 2014|Pharmacovigilance|0 Comments

ICH-GCP Principles

ICH GCP: ICH is the International Conference on Harmonisation of technical Requirements for Registration of Pharmaceuticals for Human Use.
-The current version of ICH was established in 1996 as a joint regulatory Industry/Project to improve the efficacy of process for developing and registering new medicinal products in Europe, Japan, and the US and observers: Canada, Australia, WHO, […]

By |December 8th, 2014|Clinical Research|0 Comments

Drug Development Process (Stages)

 

Drug Development Process:
Clinical Trials are highly regulated.When conducting trials with Investigational Products(Drugs) , Regulatory Authorities(RAs) require Good Clinical Practices(GCP) be followed.
-The GCP guidelines should be followed when generating clinical trial data that are intended o be submitted to Regulatory Authorities.
-The Principles established in GCP guidelines may also be applied to other clinical investigations that may […]

By |December 8th, 2014|Clinical Research|0 Comments

Clinical Research Introduction

 
Clinical Research is the study of a drug, Biologic or Device in human subjects with the intent to discover potential beneficial effects and/or determine its safety and efficacy. The product under Investigation is referred to as Investigational Product(IP).
-Clinical Research is patient oriented. It may be conducted in normal healthy volunteers or in people who have a specific disease or Illness. […]

By |December 8th, 2014|Clinical Research|0 Comments

Pharmacovigilance and Its Evolution

Pharmacovigilance:
WHO(World Health Organization) defines ” Pharmacovigilance is the Science and activities relating to the detection, Assessment, understanding and prevention of Adverse Drug Reactions(ADRs) or any other possible drug related problems.”
Goal: To ensure that the benefits of use of medicine outweighs the risks and thus safeguard the health of the population. […]

By |December 6th, 2014|Pharmacovigilance|0 Comments

CDM- Data Archiving

Clinical Data Archiving

Introduction:
Clinical data archiving includes the planning, implementing and maintaining of a repository of documents and records that contain clinical data together with any interpretive information from a clinical trial.

The clinical data archive should include a centralized table of contents for all studies.
Clinical trial documents must be maintained for a period of two years after completion of Clinical trials

[…]

By |November 17th, 2014|CDM|0 Comments

Serious Adverse Event(SAE) Reconciliation

Reconciliation of the Serious Adverse Event
Serious Adverse Event data Reconciliation is the comparison of key safety data between two data bases. (Clinical data base defined as a closed data base and a safety data base defined as an open data base.
Clinical data base defined as a closed since it can receive data only for a very short period of time. A safety data base defined as an open data base since it continues receive new SAE’s or updates of pre-existing SAE’s. […]

By |November 16th, 2014|CDM|0 Comments

CDM-Database Locking and Freezing

Database Locking or Closing the study database is fundamental in preventing inadvertent or unauthorized changes once the final analysis and reporting of the data have begun. Although important in open-label studies, it is even more critical in randomized trials in order to preserve the integrity of the randomization process once the blind has been broken. A well-defined process for closing a database and change control procedures in the event of the necessity of reopening the database are essential.
[…]

By |November 16th, 2014|CDM|0 Comments

Discrepancy Management (Query Management)

Discrepancy management is also called as query management, is a process of cleaning subject data in the Clinical Data Management Systems(CDMS). Discrepancies are raised/ created during data entry and data validation.
Where data entered does not pass validation rules then a data query may be issued to the investigative site where the clinical trial is conducted to request clarification of the entry. Data queries must not be leading (i.e. they must not suggest the correction that should be made).
For electronic CRFs only the site staff with appropriate access may modify data entries. For paper CRFs, the clinical data manager applies the data query response to the database and a copy of the data query is retained at the investigative site.
Query management is done via Data Clarification Form (DCF). […]

By |November 16th, 2014|CDM|0 Comments