Tuesday, May 21, 2013

Need of Audio / video recording of informed consent in clinical trial

The Indian health ministry will soon amend the Schedule Y of Drugs and Cosmetics (D&C) Rules to make a provision for audio and video recording of the informed consent in clinical trials. Once the necessary amendments are done by the ministry in this regard, the audio and video recording of informed consent will become mandatory in the country.

It is proposed that the investigator should make audio / video recording of the procedure of obtaining informed consent of the individual subject and maintain it for record. This will authenticate that at the time of enrollment proper care was taken to inform the subject about the pros and cons of the clinical trial and his participation was voluntary. A provision in this regard was proposed to be introduced under sub-para (4) related to ‘Informed Consent’, under para ‘2. Clinical Trials’ under Schedule Y.
DCGI further stated that it was also proposed that the trial subject should also be made aware during informed consent process, that there may be a possibility of failure of investigational product to provide intended therapeutic effect and in the case of placebo controlled trial, the placebo administered would not have therapeutic effect.
Once the ministry makes the necessary amendments in this regard, the audio/video recording of informed consent will become mandatory in the country. Besides, the audio/video recording of the informed consent process of individual subject, including procedure of providing information to the subject and his understood consent, should be maintained by the investigator for record.
The purpose behind this provision is that it will authenticate that at the time of enrolment, proper care is taken to inform the subject about the pros and cons of the clinical trial and to ensure his participation is voluntary.
The Drugs Technical Advisory Board (DTAB), the highest authority in the union health ministry on technical matters, has already given its approval to the proposal of the CDSCO to amend Schedule Y of the D&C Act to insert a clause, “An audio/video recording of the informed consent process of individual subject including procedure of providing information to the subject and his understood consent shall be maintained by the investigator for record.”
Even though it is mandatory under Schedule Y of the Drugs and Cosmetics Rules to obtain a freely given informed, written consent from each study subject before he is enrolled in a clinical trial, in the absence of audio/video proof, there have been complaints of misuse of this provision by the companies who are engaged in clinical trial business. There were reports that many a time the informed consent was taken from the participating subjects without informing them the pros and cons of the trial.
The feeling among the ministry officials is that it is the duty of the investigators to adequately inform the trial subjects about the essential elements of the study and that of the drug to be administered. The trial subjects should be made aware that the drug is a new drug and is first time being administered; its therapeutic efficacy and serious adverse reactions have not yet been well documented. The research subject should also give his consent stating that he has understood the information provided by the investigator in respect of the study and his participation in the trial is voluntary.

The officials feel that the audio and video recording of this procedure of individual subject will act as a proof of a well informed consent.

Source : http://www.cdsco.nic.in

Thursday, April 4, 2013

National Conference on Pharmaceutical and Healthcare

National Conference on 
April 30, 2013 - Ahmedabad
The Metropole Hotel, Ahmedabad

There is a National Conference on Pharmaceutical and Healthcare : Challenges & Opportunities which is organized by the ASSOCHAM (The Associated Chambers of Commerce and Industry of India) on 30 April 2013 in Ahmedabad (The Metropole Hotel).
Focus Areas
    • Market Orientation
    • Generic Drug -Clinical Research- Cloud TechnologyRegulatory Affairs & Policy issues
    • Patented Drugs & Pricing
    • Fostering innovation and Intellectual Property Rights (IPR)
    • Drug Licensing
      Who can participate                                                                                                             
      • MD/CEO/CTO/COOs other decision makers of the relevant Industries
      • Bulk Drug Manufacturers
      • Pharma exporters-Importers
      • Clinicians (Physicians, Nurses, Pharmacists
      • and Other Health)
      • Formulators/ Production Chemists
      • QC/ QA, Regulatory Personals/ Auditors
      • Patient Safety Managers
      • Educators of Healthcare/ Pharma
      • Providers
      • Research Institutes
      • Trustees of Health Care Organizations
      • Health Insurance and Health Plan Executives
      • Hospital and Health System Administrators
      • Pharma/Biotech/Medical Equipment makers
      • Risk Management Experts
      • Healthcare Consultants
      • Venture Capitalists and Investment Bankers
      • Healthcare Attorneys and In-House Counsel
      • Health Service Researchers and Health
      • Policy Expert
      how to register for this Conference                                                                                      

      To attend in this Conference click Here to download the registration form. 
      For more details go through the official website http://www.assocham.org/gct

      Monday, December 24, 2012

      Current opening in Parexel

      Organization : Parexel
      Job Title : Clinical Enrollment Manager
      Location : New Delhi (India)
      Qualification :To Degree level or equivalent nursing background
      Responsibility : 
      • Maintain updated patient database plus regular site contact and visits. 
      • Collaborate and exchange information with site staff on a regular basis.Collaborate and exchange information with CRAs (as appropriate) on a regular basis.
      • Identify opportunities for the LES service to be offered, through an appreciation of the sites¿ needs, awareness of the enrolment needs, information arising out of site meetings.
      • Contribute to the development and maintenance of an effective patient database. 
      • Review patient notes, select and present high quality, patients to fulfil enrolment needs.
      • Review site screening records to identify potential subjects. Work with local centres to facilitate a patient referral process to main centres
      • Supply (and coordinate) information for brochures, newsletters, proposals and advertisements concerning the study recruitment.
      • Organise spirometry training and co-ordinate other appropriate trainings in co-operation with site staff to ensure continuous development.
      • Undertake the full range of duties relevant to the LES to ensure that performance meets and/or exceeds the enrolment for the study.
      • Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, communicating to the site staff in an open, balanced and objective manner.  
      • Fixed period of support to the data cleaning activities
      To Apply this position Click Here

      Thursday, November 1, 2012

      ORACLE Certified training on Oracle Clinical

      APHETA invites the application for the Value Added Oracle Authorized Training on Oracle Clinical from ORACLE University. This is a once in a life time opportunity for the students to build a prosperous future by having great job opportunities in the CLINICAL DATA MANAGEMENT Industries.

       This training Program is for students of pharmacy, biotechnology, medicine, clinical Research professionals and Doctors. The program will cover the essential functional topics using Oracle Clinical Data Management tools and also expose the students to an enterprise scenario through case studies. The Program will be organized by Oracle University. The duration of the course is 40 hours which will be taking place for 5 days, 8 hours per day.

      Details of this training are as follows 
      Program Name         : Training on ORACLE Clinical
      Recognition              : From ORACLE
      Certification             : From ORACLE
      Duration                   : 40 Hours (8 hours / day)
      Mode                        : Full Time (Classroom)
      Fees                          : 45000 INR (Including tax)
      Venue                       : Apheta, New Delhi (India)

      Eligibility for this Training

      Bachelor or PG Students from :
      • Pharmacy 
      • Biotechnology 
      • Medicine 
      • Medical Professionals 
      • Clinical Research 
      • Microbiology 
      • Other Life Science Graduates.
      Venue for this Training
      Apheta Institute of Clinical Research, 389, South Ex. Tower, 201(2nd Floor), Masjid Moth, South Ex. Part - 2, New Delhi - 110049 (India)      

      Schedule for this training
      Day 1
      System Overview, Basic Study Setup
      Global Library Management

      Day 2
      Simple CRF modeling
      CRF modeling for PDF

      Day 3
      Data Entry
      Discrepancies, Data Clarification Form

      Day 4
      Validations and Derivations
      Batch Data Loading, Laboratory Overview

      Day 5
      Data Extract and Access from SAS
      Data Locking and Security, Copy Groups.
      Simulated Oracle Training content for future practice

      Topic Covered in this Training

      CRF  Review
      Browsing Oracle Clinical
      Object in Oracle Clinical
      Setup a Program, Project, Study
      Planning details, Study Design, Study Statuses
      Setup Planned Events
      Add Sites, Investigators and Patient Positions
      Manage Treatments, Schedules
      Create, Maintain Global Library objects
      Define & Copy DCM and DCI
      Lab Ranges, establish unit of Measure, standard Lab Ranges
      Lab Assignment criteria
      Validation Derivation Procedure – Edit Checks
      Entering CRF Data
      Modify DCI
      Discrepancy Management System
      Data Clarification Form
      Overview of Batch Data Loader
      Data Extracts
      QC Checking and Data Locking
      Case Study (CDM Project assignment)

      The Program will be organized by Oracle University and the following deliverable will be extended as a part of the training from Oracle University :
      1. Software Environment during the training. 
      2. Course Content
      3. Training Methodology - Slides 
      4. Completion Certificate duly signed and endorsed by Oracle University
      Process of Application for this training

      To book your seat, call to the following Number OR Visit the Institute

      Apheta Institute of Clinical Research
      389, South Ex. Tower, 201(2nd Floor)
      Masjid Moth, South Ex. Part - 2
      New Delhi - 110049
      Ph: +91 11 45782279
      Mob : +919555718847

       To apply online CLICK HERE 

      Benefit of this Training
      • Students will become trained by Oracle professionals .
      • This will provide an added advantage to their academic qualification. 
      • Students will be entertained by all the pharmaceutical, biotech, medical device and clinical data management companies who are working on Oracle. 
      • Certificate will be provided by the Oracle University. 
      • Diversity in the job prospects for the students. 
      • Enormous use of Oracle clinical by the companies, create huge number of job openings in this field