Advance Certificate Program In Clinical Research

Additional Details

Clinical Researches are specialized activities that are a vital and integral part of development of new medicines, drugs, biologics and devices. Our advanced certification programs are designed to impart the technical knowhow and competencies to enable our candidates to carry out specific responsibilities and activities pertaining to Clinical Researches. Our successful candidates have gone ahead to assume positions of Clinical Research Associate, Project Manager and Scientific Writer in various reputed firms. The unique hands-on experience based training have helps them to fast career growth in the industry.

The duration of the course is 6 months. Our courses provide specialization in the following fields:

    Advance Certificate in Clinical Trial Project Management,
    Advance Certificate in Clinical Trial Monitoring,
    Advance Certificate in Scientific Writing and Creation of Essential Documents

Eligibility:

All working professional who have competed the following degree courses and diplomas are eligible for the OCTT course. Final year students, completing their courses this year can also apply for enrolment in the program.

    B.Pharm, M.Pharm, Ph.D
    M.B.B.S, M.D, M.S, D.N.B, D.M
    B.D.S, M.D.S, B.P.T, B.Tech
    B.A.M.S, B.H.M.S, B.U.M.S
    B.Sc, M.Sc, Ph.D

All the courses have been designed comprehensively designed. The detailed course materials subjects and program elements for the 3 advanced courses are as follows:

Advance Certificate in Clinical Trial Project Management

Program Elements:

    Introduction to Clinical Research, Guidelines and Standards Governing Clinical Research
    Project Milestones Planning and Forecasting
    Cost Estimate and Financial Planning
    Logistics Planning, Vendor Selection and Management
    Clinical Study Process (multi-centric) and 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 and Milestones Tracking
    Audit(s) and Quality Assurance
    Study Closeout (trial completion, suspension, termination etc.)

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 and Responsibilities at Individual Site
    Inventory Planning and Tracking
    Clinical Trial Monitoring
    Source Document Verification (SDV)
    CRF Review, Collection and Co-ordination of Data Management Activities
    Serious Adverse Event (SAE) Review and Regulatory Compliance
    Investigational Product Accountability and Management
    Escalation, Management and Prevention of Violations/Deviations
    Tracking of Enrolments, Payments and Ongoing Correspondence
    Site Closure

Advance Certificate in Scientific Writing and 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)