Short Course on Fundamentals of Clinical Data Management (CDM)

Transcription

1 Short Course on Fundamentals of Clinical Data Management (CDM) Course offered by Advanced Clinical Data Management Centre (ACDMC), Biostatistics Resource and Training Centre, Department of Biostatistics, CMC, Vellore, India. In collaboration with the Department of Biostatistics, University of North Carolina, Chapel Hill, USA. Supported by: PATH-New Delhi and CMC-Vellore

2 Course Description The course aims to introduce the principles of Clinical Data Management (CDM) and associated international standards for conducting clinical research. The ultimate goal of the course is to make the participants comprehend the principles of CDM, International Conference on Harmonization-Good Clinical Practice (ICH-GCP), Food and Drug Administration (FDA) and impart other guidelines about data management plan (DMP), Standard Operating Procedures (SOP) writing, developing case report forms (CRFs), data management systems, data entry methods, data validation, query management, database lock and archival. The 'OpenClinica' database system will be used in practical session during the workshop. The design and structure of Oracle Clinical (OC) software for data management will also be presented. Who should apply? Epidemiologists, biostatisticians and software professionals who are involved in clinical research are encouraged to participate. Sponsorship PATH, New Delhi will support 20 participants from varied government, academic and not-for-profit institutions with regard to hospitality (accommodation, course fee and food expenses). However, participants will have to bear their own travel expenditure. Selection Process Those who are interested to apply for the PATH support for local hospitality are requested to write a brief background about one s institution and a justification on why one should be supported. A panel will be responsible to select the participants. Participants from CMC could register for the program free of cost.

3 Course Fee Participants from the industry and Clinical Research Organizations (CROs) could register for the program for a total fee of Rs.10, 000/- that would be inclusive of course kit, lunch, snacks and tea. The full amount of the course fee should be paid by August 20, The payment can be made by Demand Draft in favour of Christian Medical College Vellore Association Account, payable at Vellore. The course fees will not be refunded once the payment is done. Venue Biostatistics Resource and Training Center (BRTC) Department of Biostatistics, (Adjacent to Christian Medical College Chapel, Bagayam Campus), Christian Medical College, Bagayam, Vellore, , Tamil Nadu, India. Accommodation The organizers would arrange for accommodation at the college campus for the participants on request. However, this depends on the availability of guest houses and women participants would be given priority. The organizers would arrange for the accommodation for PATH sponsored participants. Also, please find attached details of hotels in Vellore for reference. Number of participant Admissions will be purely made on first-come-first-served basis and limited to 30 seats. Course Coordinator Dr. L. Jeyaseelan, Department of Biostatistics, Christian Medical College, Bagayam, Vellore biostats@cmcvellore.ac.in Phone: (0416) , Website: Secretariat / Contact person: Mr. C. Jayaprakash

4 About Faculty Dr Shrikant Bangdiwala is a Professor, Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina (UNC),Chapel Hill. He has extensive experience in the design, conduct and analysis of multi-center studies, of having worked on clinical and community-based randomized controlled trials in cancer prevention, congestive heart failure, cardiovascular risk factors and functional bowel disease as a member of the Collaborative Studies Coordinating Center of UNC. Dr Bangdiwala also has vast experience as a member and chair of various data and safety monitoring boards (DSMB) for studies in ophthalmology, HIV/AIDS, and cardiology. Currently, he chairs the Multinational DSMB for the Division of AIDS at NIH and is a member of the Board of Scientific Counselors of the National Center for Injury Prevention and Control at the Centers for Disease Control & Prevention and of the Gastrointestinal Drugs Advisory Committee of the FDA. He also holds a faculty position at the University of Chile, University of South Africa and at Christian Medical College, Vellore, India. His statistical research interest includes non-parametric methods, methodology for clinical trials, reliability and validity of diagnostic tests and graphical methods for descriptive analyses. Ms Hope Bryan is a Senior Information Technology Manager and Director of Data Management Computing and Network Support for the Collaborative Studies Coordinating Center (CSCC), Department of Biostatistics, University of North Carolina, Chapel Hill. Ms Bryan has over 20 years of experience in CDM, including statistical computing, data management and data management systems design for multicenter collaborative epidemiological studies and randomized controlled trials. She has co-taught graduate level courses on data management for clinical and public health research. She has developed and supervised the design, implementation and training for data management systems developed at CSCC and has immense experience with many data management platforms, data collection approaches and technologies; She also supervises the IT and network administration staff at CSCC.

5 Mr Rob Tomsick is an Application Analyst working for the Collaborative Studies Coordinating Center at UNC. He is the architect and team leader for the development of center s data management software, CDART. He has several years of experience in developing enterprise-grade software and has extensive knowledge of commercial software development practices. Mr Tomsick participates in various open source projects and holds an undergraduate degree in Computer Science from the University of St. Andrews. Mr A Rajagopal is an Information Technology Manager and Coordinator at Clinical Data Management Centre, Department of Biostatistics, Christian Medical College, Vellore. His area of specialization includes Clinical Data Management (CDM), Data Ware Housing and Business Intelligence. He has coordinated quite a number of CDM projects for clinical trials. He has been teaching health data management for the Masters Program at this Department and is also one of the resource persons for software related training programs and workshops. His involvement in Clinical Data Management includes Data Management Plan (DMP), CRF developments, Database design, Electronic Data Capture (EDC), SOPs development, data lock and archival. Mr K Omprakash is a Senior Software Engineer at the Department of Biostatistics, Christian Medical College, Vellore. He has rich experience in Web Design/Standalone projects, proficient in.net, PHP, MYSQL, PostgreSQL and Photo shop. He is known to deliver unique creative projects as he has good understanding of the project lifecycle with excellent skills. Apart from having developed nmaster (Sample size) and Trial Data Analyzer Software for the department, he acts as a Coordinator for the Clinical Trial projects that are assigned to this department.

6 Course content Introduction to Clinical Trials Basic design considerations Need for sound data management Guidelines and regulatory requirements (ICH GCP and FDA 21 CFR Part 11) Overview of Clinical Data Management Objective, Function and Lifecycle Types and Components of a DM system capture, accuracy, storage, retrieval, security Data Management Plan (DMP) Standard Operating Procedures (SOPs) Generating Case Report Forms (CRFs) Standard CRF Components CRF Filling guidelines, Form versions and Examples of problems Data capture considerations Paper, remote, direct systems features, pros & cons Validation and quality assurance principles in DMS; testing, key fields Data validation principles data cleaning Validation Check Specification (VCS) document, DM system validation and Regulatory requirements Documents & reports Who gets what, when Timing of data flow, Reports on SAEs, recruitment, reports for DSMB Freezing data flow, Unblinding principles, Naming conventions for data files and variables Real time reporting (BIRT software) Extraction to databases file formatting, labels & value formats Security & access controls Why is it important; password complexity, who can see what permission models, What is a good security system; Protecting interesting vs important assets; least privilege Physical, operational, & technical security Documentation audit trail Implementation Training personnel Randomization processes Storage & archival Total costs

7 OpenClinica CDM System Introduction Creating New study, New User, ecrfs and Events Assigning CRFs to Events Adding subjects to study, Assigning Events to subjects Data Entry (First/Second) Incorporating Data Validation (QC) Query Management Data Extraction Oracle Clinical (OC) Introduction, Modules and Features Data Lock Data Archival Breakout session and Group presentations by participants

8 FORMAT OF APPLICATION NAME IN CAPITAL (FOR CERTIFICATE PURPOSE) : AGE : SEX : M / F DESIGNATION ACTIVITIES INSTITUTION/COMPANY NAME ADDRESS STATE : PHONE & MOBILE : PERSONAL OFFICIAL EDUCATIONAL BACKGROUND DEGREE AREA OF CONCENTRATION ACCOMMODATION : REQUIRED / NOT REQUIRED (Priority will be given to the female participants) DD AMOUNT : RS. DATE : DD NUMBER : BANK : NOTE: 1) AFTER REGISTRATION IF CANCELLED THE COURSE FEE WILL NOT BE REFUNDED 2) IF SEPARATE RECEIPT IS REQUIRED, PLEASE DO NOT SEND THE COMBINED DD Department of Biostatistics, CMC, Vellore-2

9 List of Hotels available in Vellore Hotel name Darling Residency Grand Krishna Hotel Surabhi International Baby Residency Aavanaa Inn River View Mount Paradise Sri Srinivasar Residency Sri Annamalaiyar Residency Kumaran's Millennium Residency Hotel Khanna Single non AC Double non AC Single AC Vellore city STD code is Double AC 1400/- 1700/- 2000/- 3000/- 1400/- 1700/- 1200/- 1400/- 1000/- 1300/- 1400/- 1700/- 1500/- 1800/- 550/- 650/- 700/- 850/- 1000/- 1100/- Phone nos Distance from Venue (approx) 3.5 kms 15 kms 3.5 kms 3 kms 6 kms 7 kms 10 kms 7 kms 1500/- 1500/ kms 420/- 605/- 550/- 950/ kms. 550/- 799/ kms. Park Avenue 500/- 730/ kms. Lingam Residency 450/- 450/- 700/- 700/ kms. Koona Residency 525/- 825/ kms. Arunachalam Lodge 400/- 850/ kms. Hotel Solai 180/- 294/- 660/ kms. AMP Lodge 300/- 400/ Km. Ananda Bhavan vimdes@rediffmail.com Note: Rates may be subject to revision 250/ Km.