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Clinical Data Management
1. PRESENTATION ON CLINICAL DATA MANAGEMENT SYSTEM & SOFTWARES BY: SNIGDHA DEBNATH BIOINFORMATICS INSTITUTE OF INDIA
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3. INDEX AKAZA’S OPENCLINICA SOFTWARE SIGMASOFT’S DMSYS SOFTWARE PROGENY CLINICAL SOFTWARE ABOUT BII BII’s PROGRAMS IN CLINICAL TRIALS
4. CLINICAL DATA MANAGEMENT SYSTEM INTRODUCTION A Clinical Data Management System or CDMS is used in clinical research to manage the data generated by the conduction of a clinical trial. The clinical trial data gathered at the investigator site in the Case Report Form(CRF) is stored in the CDMS. CRF is a paper or electronic questionnaire, used as a tool by the sponsor of the clinical trial to collect data on each patient from each participating site. CDMS also performs coding of data. Standard dictionaries of Adverse Event Terms (Multiple terms, developed by different cancer therapy modalities, e.g. acute/late effect, side effect, complication, etc.) and Medication/Drug Names can be loaded into the CDMS,enabling matching of common abbreviations and mapping them to the correct term. For e.g., ASA could be mapped to Aspirin. Popular Adverse Event dictionaries : MedDRA and WHOART Popular Medication dictionaries : COSTART and WHO-DRUG. At the end of the clinical trial, the dataset in the CDMS is analysed and sent to the regulatory authorities for approval.
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23. ABOUT BII - PROGRAMS OFFERED Established in 2002, Bioinformatics Institute of India (BII), an initiative of Confrere Education Society, is a non profit making educational, R&D and development centre. It stands as a reputed and pioneering institution for imparting quality education and training in the different emerging disciplines of Life Sciences. BII is today recognized across the globe as a premier institution offering programs in the diverse areas of Bioinformatics, Clinical Trials, Pharma Regulatory affairs, Pharma Quality Assurance and Control, Drug Design and Patenting, IPR and Biotechnology etc. SUBJECT AREAS OF SPECIALISATION CLINICAL TRIALS DRUG DESIGN AND PATENTING INTELLECTUAL PROPERTY RIGHTS BIOTECHNOLOGY PHARMA QUALITY ASSURANCE AND CONTROL BIOINFORMATICS PHARMA REGULATORY AFFAIRS
24. ABOUT BII – PROGRAMS OFFERED These training programs are offered through various modes including distance participation, e-learning, classroom, etc. Workshops, Corporate trainings, etc. are also conducted from time to time. The quarterly journal Bioinformatics – Trends is one of its kind journal in India. The institute also supplies multimedia and corporate training kits to governments, private bodies and individuals in its diverse areas of expertise. MODES OF TRAINING PROGRAMS DISTANCE PARTICIPATION CLASSROOM PROGRAMS CORPORATE TRAININGS PUBLICATIONS E-LEARNING PROGRAMS WORKSHOPS PROJECTS/TRAININGS
25. BII’s PROGRAMS IN CLINICAL TRIALS INDUSTRY PROGRAM IN CLINICAL TRIALS, RESEARCH & ADMINISTRATION (12 MONTHS DISTANCE PARTICIPATION PROGRAM) The prime objective of this program is to provide quality inputs in the area of Clinical Trial, Research & Administration, to working professionals and individuals who have completed their education and are willing to contribute to this area. It also aims to develop documentation/research writing expertise in the Clinical Trial, Research and Administration sector. Promotion of spread, enhancement and sharing of knowledge in this field is of great importance. The core areas of studies are comprised in the 8-Modules Course Structure: Module I- Clinical Trials Module II- Contract Research Module III- Contract Research and Clinical Trial Environment Module IV- ICH -GCP Guidelines - International Conference of Harmonisation Module V- ICMR -Guidelines on Biomedical Research on Human Subjects Module VI- SCHEDULE Y Module VII- Biostatistics Module VIII- Research Study Program Deliverables include : Training Kits comprising of Reference Materials and Free Lecture CDs, Support via Internet, Email & Telephone and Information exchange via BII Blog. Graduates/Final year students from any discipline can apply by downloading form and submitting it with BII Program Participation Fee of Rs.10,000(exam fee exclusive).
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28. BII’s PROGRAMS IN CLINICAL TRIALS ONLINE PROGRAM IN CLINICAL TRIALS & RESEARCH (3 MONTHS e-LEARNING PROGRAM) The prime objective of this program is to help to understand basics of clinical trials. It has been specifically designed to answer scientific questions and to find better ways to treat individuals with a specific disease. The core areas of studies are comprised as follows: Teaching and learning methods include content documents, directed reading, a range of on-line systems of information retrieval, literature reviews and moderated on-line seminars. Graduates in any discipline can apply . Highly motivated students pursuing graduation /Diplomas courses in Pharmaceutical science/chemistry and allied areas are also eligible . Course fee is INR 5000. Bioethics Clinical Trial Regulatory Affairs Clinical Trial Business Environment Clinical Trial Delivery Model Clinical Trial Team Clinical Trial Informatics Design of Experiments Bioavailability Studies Clinical Trial Statistics Patient Recruitment Good Clinical Trial Practices Features of Clinical Trials Basics of Clinical Trials & Clinical Research
29. BII’s PROGRAMS IN CLINICAL TRIALS CLINICAL TRIALS CORPORATE TRAINING KIT The main objective of the course is to provide individuals with a complete knowledge of clinical trials from study start-up to closure. It covers the whole spectra of issues critical to the successful operation of clinical trials-its design, responsibilities of the study team, safety measures, the regulatory framework that governs clinical trials and the financial aspect of it. It also gives an overview of the various soft wares used in clinical trials. The core areas of studies are comprised as follows: Program Deliverables include : An Educational VCD providing Lecture sessions, an Audio enabled PowerPoint Presentation of Clinical Trials, Electronic Self Evaluation Workbook for Self assessment and practice, a Book on Clinical Trials Published by BII & User manual. The kit is beneficial to pharmaceutical companies-established and de novo, research or health organizations involved in Clinical Trial processes, govt. organisations, NGOs, motivated students/individuals doing pharmaceutical studies,etc. and costs Rs.4000/-. Clinical Trial Business Environment Clinical Trial Delivery Model Bioavailability Studies Adverse Event Reporting Audit of Clinical Trial Patient Recruitment Concepts in Clinical Trials Initiation of Clinical Trials Bioethics Clinical Trial Regulatory Affairs Conduct of Clinical Trial Design of Experiments Clinical Trial Statistics Clinical Trial informatics Good Clinical Trial Practices Clinical Trial Team Introduction to Clinical Trials
30. THANK YOU For Further Details & Enquiries, Contact: Bioinformatics Institute of India C-56A / 28, Sector – 62 Noida – 2010301, U.P Tel: 0120-4320801/02 Mobile: 9818473366, 9810535368 Email: [email_address] Visit: www.bii.in