Information Brochure-ACCR.doc.doc.doc

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Information Brochure-ACCR.doc.doc.doc

  1. 1. ACCRTM v-1 Advance Certificate Program(s) in Clinical Research (ACCRTM ) Training Clinical Research Professionals: An Unmet Need India is today poised as one of the favorable destination for conducting global clinical trials in terms of large patient populations, skilled manpower, cost effectiveness, favorable economic & IP environment etc. Clinical research is a highly specialized field that requires specific training to carry out various job functions. The need and complexity of the specific training at the level of CRA(s)/Monitor(s)/QA Auditor(s) increases as they move up the professional ladder thereby shifting the focus from ‘trouble shooting’ to ‘planning & forecasting’. Advanced Certificate Program(s) in Clinical Research are aimed at imparting the effective Project Management, Clinical Trial Monitoring and Scientific Writing & Creation of Essential Documents skills required for the professional growth & competency development at the level of CRA(s)/Monitor(s)/QA Auditor(s) and allied clinical research professionals. Program Objective(s): • To provide an in-depth training & opportunity for skills development on Project Management, Clinical Trial Monitoring, Scientific Writing & Creation of Essential Documents. • To uncover the hidden pitfalls of clinical study process for a sound milestone planning and execution of the study in a time bound & flawless manner. • To nurture the culture of 100% GCP & regulatory compliance at any time-point. • Competency development Target Audience: • Clinical research professionals employed in Pharmaceutical companies, Contract research organizations (CROs), Research & Academic Institutions etc. • Allied professionals with basic level knowledge on clinical trial processes who aspire to pursue active clinical research stream. • Investigator Site Co-ordinators About the Company: Advance Certificate Program(s) are being run by Catalyst Clinical Services Pvt. Ltd. (Catalyst). Catalyst is a clinical development organization with a prime focus on clinical research training & development activities. With regards to clinical research training Catalyst has made pioneering initiatives in terms of, • Clinical QuestTM (India’s first & only publication for clinical research professionals); • Professional Diploma in Clinical Research (PDCRTM - more than 1550 participants from 131 cities across 23 states have already enrolled for this program); • Workshop(s) on Clinical Trials Management (more than 200 professionals have taken part in highly specialized workshops across the country); • Oncology Clinical Trials Training; Catalyst Clinical Services Pvt. Ltd. Page 1 of 5
  2. 2. ACCRTM v-1 • Training Program for Ethics Committee Members; • Training Program for Clinical Investigator & Site Personnel; • Training Program on 21 CFR Part 11; • Orientation lectures on clinical research etc. Program Director: Sanjay Gupta, Director-Clinical Operations & QA with Catalyst Clinical Services Pvt. Ltd has over 9 years of exclusive clinical research experience. He has personally conducted and supervised over 30 clinical trials (Global registration, Phase II CTNRs, IITs etc.) across a wide range of therapeutic areas including oncology, endocrinology, CNS, critical care, andrology etc. He has presented his research work in various International Journals & Conferences including American Society of Clinical Oncology (ASCO), British Journal of Cancer (BJC) and Seminars in Oncology etc. He has authored 5 books and has been instrumental in taking various clinical research-training initiatives such as, • Chief Editor, Clinical QuestTM • Course Director, Professional Diploma in Clinical Research (PDCRTM ) • Convener, Workshop(s) on Clinical Trials Methodology & Management • Mentor, Orientation lectures on clinical research to various stakeholders (Investigators, ERBs, students etc.) across the country. • He is the founder member of SPECT (Society for the Promotion of Ethical Clinical Trials) & also the network co-ordinator (India) of a Cancer Research Network setup by University of Oxford, U. K. Advance Certificate Program(s) Overview: Advance Certificate Program(s) consists of multi-disciplinary approach of skills enhancement including Induction, Self-reading, Assignment, Project Work & Award of Credits. Program Element Duration Mode Description Induction 1 hour Telephone 1:1 interaction between the program director and the participant in order to ascertain the developmental needs, focus area and intensity of training. Self-Reading 80 days Study Material Customized study material holistically covering the program curriculum. Assignment 10 days Paper Based Participant’s perception & opinion on pre- designed case studies. Project Work 60 days Dissertation Dissertation submission on a relevant topic that has been mutually agreed between the participant & the program co-ordinator. Award of Credits 30 days Certification Evaluation of project work by experts, Catalyst Clinical Services Pvt. Ltd. Page 2 of 5
  3. 3. ACCRTM v-1 compilation of credits & certification. Curriculum: Course – 1. Advance Certificate in Clinical Trial Project Management Program Elements: • Introduction to Clinical Research, Guidelines and Standards Governing Clinical Research • Project Milestones Planning & Forecasting • Cost Estimate & Financial Planning • Logistics Planning, Vendor Selection & Management • Clinical Study Process (multi-centric) & Creation of Trial Master File(s) • Management of Regulatory Document Submission • Co-ordination of Individual Site Set-up Activities • Import/ Export Authorization • Organization of Investigator Training Meeting • Study Initiation, Conduct & Milestones Tracking • Audit(s) & Quality Assurance • Study Closeout (trial completion, suspension, termination etc.) Enrolment: Offered throughout the year Program Duration: 6 months Program Fee: Rs. 9600/- Course – 2. Advance Certificate in Clinical Trial Monitoring Program Elements: • Introduction to Clinical Research, Guidelines and Standards Governing Clinical Research • Site Initiation, Review of Essential Trial Documents, Delegation of Duties & Responsibilities at Individual Site • Inventory Planning & Tracking • Clinical Trial Monitoring • Source Document Verification (SDV) • CRF Review, Collection & Co-ordination of Data Management Activities • Serious Adverse Event (SAE) Review & Regulatory Compliance • Investigational Product Accountability & Management • Escalation, Management & Prevention of Violations/Deviations • Tracking of Enrolments, Payments & Ongoing Correspondence • Site Closure Enrolment: Offered throughout the year Program Duration: 6 months Program Fee: Rs. 8000/- Catalyst Clinical Services Pvt. Ltd. Page 3 of 5
  4. 4. ACCRTM v-1 Course – 3. Advance Certificate in Scientific Writing & Creation of Essential Documents Program Elements: • Introduction to Clinical Research, Guidelines and Standards Governing Clinical Research • Development of Standard Operating Procedures (SOPs) • Protocol • Informed Consent Document (ICD) • Clinical Report Form (CRF) • Data Validation Plan (DVP) • Clinical Study Report (CSR) Enrolment: Offered throughout the year Program Duration: 6 months Program Fee: Rs. 7500/- Eligibility: Personnel having a Bachelor's/Master’s/Doctorate in Pharmacy/Life Sciences/Medical Sciences are eligible for enrolment in Advance Certificate Program(s) based on personal interaction with the program director. Candidates who have successfully completed PDCRTM are also eligible for enrolment in Advance Certificate Program(s). Candidates are required to send their completed applications along with a Demand Draft of ‘requisite program fee’ drawn in favor of “Catalyst Clinical Services Pvt. Ltd.” payable at Delhi. Candidates are advised to write their name and address at the back of demand draft. Evaluation System: Advance Certificate Program(s) follows a credit system. Credits would be awarded at three levels: Level Total Credits Minimum Qualifying Credits Assignment 60 36 Project Work 40 24 The grading system for overall credits is as follows: ≥ 80 credits 70-79 credits 60-69 credits < 60 credits Excellent Good Satisfactory Unsatisfactory Participants are required to secure minimum qualifying credits at individual level and an overall 60 (and above) cumulative credits for the successful completion of the respective program. Participants unable to secure minimum qualifying credits would be given one more chance to attempt the assignment and/or project work. A fee of Rs.5000/ would be applicable for all reappearing participants. Failure to qualify the repeat chance would require a fresh enrolment (if desired by the participant). Catalyst Clinical Services Pvt. Ltd. Page 4 of 5 Candidates can enroll for more than one Program at the same time
  5. 5. ACCRTM v-1 Applications completed in all respects should be sent to: Program Director: ACCRTM , Catalyst Clinical Services Pvt. Ltd., 119, State Bank Colony, G.T. Karnal Road, Delhi – 110 009 (India), Ph: 011-42384005, Telefax: 011-27466248 Email: contact@catalystclinicalservices.com Catalyst Clinical Services Pvt. Ltd. Page 5 of 5
  6. 6. ACCRTM v-1 Applications completed in all respects should be sent to: Program Director: ACCRTM , Catalyst Clinical Services Pvt. Ltd., 119, State Bank Colony, G.T. Karnal Road, Delhi – 110 009 (India), Ph: 011-42384005, Telefax: 011-27466248 Email: contact@catalystclinicalservices.com Catalyst Clinical Services Pvt. Ltd. Page 5 of 5

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