Sanjeevani Clinical Research Academy

Module–I Clinical Trials and Clinical Trials Environment

SYLLABUS OF PROGRAM

IN CLINICAL TRIAL,RESEARCH AND DATA MANAGEMENT

Module-II Statistics for Clinical Trials

Module-III Clinical Data Management

Module-IV Contract Research

Module-V Regulatory Affairs, GCP, Pharmacovigilance and Ethics

Module-VI Practical Medical Writing and Documentation

Module-VII Research Study

PROGRAM IN CLINICAL TRIAL, RESEARCH AND DATA MANAGEMENT

About Introduction, Features of clinical trials, Bioavailability Studies, Designing of Clinical Trials Studies, Clinical Trials Delivery Model, Clinical Trial Environment, Non-Clinical Safety Studies, Choice of Control Group, Patient Recruitment, Case Studies & Audit Of Clinical Trials.

CLINICAL TRIALS & CLINICAL TRIALS ENVIRONMENT

MODULE-I

Clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices. These trials can only take place once satisfactory information has been gathered on the quality of the product and its non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country

where the trial is taking place.

CONTENT

PROGRAM IN CLINICAL TRIAL, RESEARCH AND DATA MANAGEMENT

STATISTICS FOR CLINICAL TRIALS

About Types of Data, Descriptive Statistics, measure of central tendency, percentiles variability measure, normal distribution, statistical inference, sampling distribution, The Central Limit theorem, interval estimation-distribution, types of error, ANOVA, chi- square, The randomized complete block design, regression and correlation.

MODULE-II

Statistics play an essential part throughout any clinical trial, from planning,conduct, interim analysis and final analysis and reporting. The statistician devisesthe randomization schedules. Advice on sample size; criteria for measuring treatmentdifferences and analysis of response rates are all the responsibility of the statistician. Time to an event of interest is often used as an endpoint for evaluation of therapies in clinical trials. Time to recurrence of disease, duration of complete remission, and overall survival are examples.

CONTENT

PROGRAM IN CLINICAL TRIAL, RESEARCH AND DATA MANAGEMENT

MODULE-III

CLINICAL DATA MANAGEMENT

Introduction, data definition, clinical databases and types, Computers in clinical trials, Data Acquisition and storage, Electronic Data Capture, CRF (clinical research form), coding of data, software tools,SAS programming, program documentation, program validation, and development of data entry platforms.

A Clinical Data Management System or CDMS is used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the Case Report Form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ different means to verify the entry. The most popular method being double data entry.

Once the data has been screened for typographical errors, the data can be validated to check for logical errors. An example is a check of the subject's age to ensure that they are within the inclusion criteria for the study. These errors are raised for review to determine if there is an error in the data or clarification from the investigator is required.

CONTENT

PROGRAM IN CLINICAL TRIAL, RESEARCH AND DATA MANAGEMENT

MODULE-IV

CONTRACT RESEARCH

Introduction of Contract Research Organization, Contract Research Areas, Delivery Models, Business Environment, Information Source, IT and Contract Research, Regulatory affairs and contract research and case- studies.

A Contract Research Organization (CRO) is an organization that offers clients a wide range of pharmaceutical research services. In the Code of Federal Regulations (CFR), the U.S. Food and Drug Administration Regulations state that a CRO is "a person [i.e., a legal person, which may be a corporation] that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration

CONTENT

PROGRAM IN CLINICAL TRIAL, RESEARCH AND DATA MANAGEMENT

MODULE-V

Regulatory affairs, Good clinical Practices, Pharmacovigilance and Ethics

Schedule-Y, application of permission, approval of clinical trials, responsibility of sponsor, informed consent, principles of ICH-GCP, Institutional Review Board/Independent Ethics Committee (IRB/IEC), Bioethics, Ethics, Pharmacovigilance, Drug approvals , Drug Registry and safety.

Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, herbalism and traditional medicines with a view to identifying new information about hazards associated with medicines preventing harm to patients.

Good Clinical Practice is an international quality standard that isprovided by International conference of Harmonization (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials.

CONTENT

PROGRAM IN CLINICAL TRIAL, RESEARCH AND DATA MANAGEMENT

MODULE-VI

Practical Medical Writing and documentation

Preparation of Protocol, Design a Research Study, Tabulation of Data, Analysis, Technical writing of a Report and Drafting of the protocol for clinical trial study.

CONTENT

PROGRAM IN CLINICAL TRIAL, RESEARCH AND DATA MANAGEMENT

Medical writing is the activity of writing scientific documentation bysomeone who is a specialized writer (a medical writer) and is generallynot one of the scientists or doctors who performed the research. A medical writer is anyone engaged in communication in the medical or allied professions and sciences. The purpose of medical writing is to have a writing specialist work together with the people who produce the scientific data in order to create documents that effectively and clearly express the messages the data have to tell. The medical writer also serves to make sure that the documents comply with any regulatory, journal or other guidelines in terms of content, format and structure.

MODULE-VII

To provide skills to scrutinize information, to critically analyze and carry out research, and to communicate effectively.

To describe the uses and applications of the main types of intervention studies: clinical trials and community trials.

To describe the essential features and stages in the conduct of a clinical trial, and the role of randomization, use of placebo, blinding / masking and intention-to-treat analysis.

To discuss the ethical issues involved in the conduct of a clinical trial.

Arranging site visits for practical exposure of the students.

RESEARCH STUDY

PROGRAM IN CLINICAL TRIAL, RESEARCH AND DATA MANAGEMENT

CAREER PROSPECTS AND JOB PROFILES IN CLINICAL RESEARCH

Career prospects include a professional career in Clinical Research industry either as a clinical investigator, site coordinator in at a hospital conducting clinical investigations or CRO (Clinical Research Organization). Jobs are also available in pharmaceutical industry, drug development, medical writing, biostatistics or as a Manager of Clinical Project, Clinical Research Business Development, Clinical Operations, Data Management, Regulatory Affairs and Auditing of Clinical Trials. You can build up your carrier in clinical trials as:

The main function of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a Contract Research Organization (CRO). A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRF) and communicates with clinical research investigators.

Clinical Research Associate

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Clinical Research Investigator

Conduct BA/BE studies as per cGCP guidelines, Writing/revising SOP for clinical operations. Review of protocols, Investigators Brochures, ICF and CRFs Protocol, CRF and ICF preparation Plan & conduct of BA/BEIEC/IRB affairs-GC.

Study Coordinator

Study coordinators work directly with study volunteers, providing them safety and protection while collecting and managing the study data. They promote, advertise, and conduct telephone and face-to-face screenings to recruit volunteers. During the study process, they assess volunteer condition and coordinate ongoing clinical/laboratory testing and physical exams. Coordinators may assess vital signs (height, weight, blood pressure, pulse), and some are trained to collect blood/urine specimens and perform lung function testing. Study coordinators follow up with volunteers after the study and manage a great deal of paperwork, electronic correspondence and data.

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Data Manager / Biostatistician

Biostatisticians collaborate with researchers to design studies that may show the seriousness of a disease, predict a specific disease's seriousness, evaluate a new treatment, assess the safety and effectiveness of medications and increase knowledge of environmental issues. Additionally, biostatisticians participate in research design, data collection, choosing and implementing appropriate methodologies, and interpreting the results.

Regulatory Affairs Manager

Responsible for review & registration of documents as per country specific guidelines for export. Evaluation of technical data & answer to various related queries as per regulated & semi – regulated requirements. Liaison with regulatory authorities.

Clinical Trials Auditor Conducts audits for the regulatory/QA function within the Clinical Trials Department in order to help assure compliance with GLP/GCP in accordance with established FDA regulations and company policies and standard operating procedures Job Requirements Normally B.A./B.S. in Science w/1-2 years of experience.

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Clinical Project Manager

Responsible for ensuring compliance across projects to all applicable Clinical Trial regulations, guidelines, SOPs Protocols and procedures. Coordinate project start-up, project maintenance and project close-out activities, Serve as the primary contact for the Sponsor and all project team members, Direct supervisory responsibility for project Coordinators, project Assistants, CRAs, etc.

Clinical Research Manager

Manage interdisciplinary clinical research projects, as Project. Supervise, train, and mentor Clinical Research staff, Approve investigator study budgets and contracts, Review and approve regulatory and administrative documents, develop protocols and approve Case Report Forms (CRFs), Review Tables and Listings generated from study data. Author Clinical Study Reports. Train CRAs on monitoring, internal procedures, and query, resolution.

Business Development Manager

Identify potential clients & establish business relations & convert into real business. Responsible for all Business Development functions Meeting new clients, following up on leads, CRM. Continuously monitor the Competition and Global Market.

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Drug Safety Associate

Manage and relay drug safety information, maintain current knowledge of global drug safety regulations, summaries clinical safety data, participate in meetings with potential and actual study sponsors, write narratives with medical input from a physician, report SADRs to the Regulatory Authorities, participate in the training of operational staff on drug safety issues, quality control work of other staff in the department, take on any other task as assigned by the manager or Medical Director within the capabilities of the Drug Safety Associate.

Medical Writer To prepare high quality documents, manuscripts, abstracts and other communication tools (slide presentations, posters etc.) for publishing in indexed scientific/medical journals or for presentation in scientific/Health Authority meetings.

Clinical Data Manager

The Clinical Data Manager (CDM) ensures complete, accurate and consistent data for reporting to regulatory bodies. A CDM is involved in the setting up, running and reporting of clinical trials. The CDM processes data using a range of computer applications and database systems to support collection, cleaning and management of patient data.

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