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CERTIFICATE COURSES

ACE specializes in conducting workshops in Clinical Research for all those involved in the clinical research activities. ACE training programs are addressed by both international and national team of clinical experts with focus on the tools and tactics necessary in clinical research industry.

Our Mission: To provide cost-effective solutions to corporate and government organizations by our training and application skills.
Our Vision: To become the world's premier training institute of clinical research.
Our Experience: We have conducted more than 30 workshops, both in-house and customized at various locations.

ACE offers certificate courses in two modes:

Inhouse courses - Inhouse courses are organized in a timely manner at ACE premises. The announcements for the same are made on the website

Customized courses - Customized training courses are designed as per the requirements of the organization, at location & dates that suit the organization.

You can choose specific key areas in which your personnel require training from our range of standard training courses.

How it works
Our programs are distinctive, designed around the specific needs and goals of our clients. Our team will work closely with your
company to understand your needs and create a custom program that will deliver the results you expect. The programs are
flexible in design and conduct.

ACE Advantage
Our workshops are highly participative giving you an opportunity to explore issues and practice skills during individual and group
exercises. There will be ample opportunity to ask questions about project work. Checklists, questionnaires, guides, worksheets
and samples are used to provide guidance in developing new skills. Numerous tips and techniques are contained in the course
materials and reinforced during exercises.


Topics we offer


1] Foundations of Clinical Research and GCP

2] Ethics Committee- Composition and Function

3] Advanced module on Protocol Design

4] Overview of clinical Research and GCP for investigators

5] Regulations in Clinical Research

6] Designing case report forms

7] Clinical Research : From Theory to practice (Advanced GCP)

8] Advanced GCP course and BA/BE Studies

9] Biostatistics and Data Management

Three new certificate courses in the following areas are under development -

  • Monitoring and soft skills for monitors
  • Quality assurance in clinical research
  • Medical writing

FOUNDATIONS OF CLINICAL RESEARCH & GCP

Objectives:
The workshop will provide an overview of the drug development process and a background of clinical research with emphasis on
the Good Clinical Practice Guidelines and Amended Schedule Y, through highly interactive with many exercises and discussions

Topics to be covered:  

  • Overview of Drug Development & Clinical Trial Process
  • ICH-GCP & Indian GCP Regulations
  • Amended Schedule Y
  • Role of IEC or IRB in Clinical Research
  • Informed Consent Process
  • Sponsor Responsibilities
  • Investigator Responsibilities
  • Safety Reporting
  • Monitoring a Clinical Study
  • Supply and Handling of Investigational Product
  • Audit and Inspections
  • Data Management & Statistics in Clinical Research

Who should attend?
The workshop is targeted towards individuals working in clinical research including investigators, clinical research personnel,
regulatory scientists, quality control/assurance personnel, medical writers, data managers and others who need an introduction to
the conduct, monitoring and/or quality in clinical trials.



ETHICS COMMITTEE- COMPOSITION AND FUNCTION

This one day course will provide you with a background of the evolution of ethics committees and help you understand the
structure and functioning of the Independent Ethics committee (IEC) or Institutional Review Board (IRB).It will also focus on the
GCP requirements for clinical trials that pertain to ethics, from the perspective of sponsors and investigators.
An outline of the course covering different topics is as follows –

Origin of concept of ethical review and the need for it.

  • Independent Ethics Committees (IECs) –composition and function
  • Sponsor Responsibilities
  • Investigator Responsibilities

The program will be highly interactive with Q&A sessions, casestudies and group discussions

Who should attend?
This course is designed for individuals who would benefit from an in-depth understanding on the need for ethics committees,
their structure and functioning according to ICH GCP guidelines.  Those connected to hospital administration and wanting to
constitute ethics committees, those who are already members of an ethics committee, and those working in quality assurance
or regulatory compliance may benefit from the course.



ADVANCED MODULE ON PROTOCOL DESIGN

This two day course will help you understand different components of protocol and appreciate interrelationships between
components. It will also help you in comprehend design of case report form (CRF) and practice preparation of protocol & CRF.

An outline of the course covering different topics is as follows –

  • Overview of protocol writing-
  • Background and Objectives
  • Study Designs
  • Criteria of Selection & Withdrawal
  • Drug Treatments and Placebo
  • End-points and Variables
  • Statistical Issues
  • Case Report form (CRF) design 
  • Ethical considerations
  • Protocol for Bioequivalence study

The course will be highly interactive with group exercises of protocol preparation and CRF designing.

Who should attend?
Medical Advisors, Physicians and all clinical research personnel responsible for implementation of clinical trials



OVERVIEW OF CLINICAL RESEARCH AND GCP FOR INVESTIGATORS

This one day course will provide an overview of clinical research and Good Clinical Practice (GCP) guidelines requirements
An outline of the course covering different topics is as follows –

  • Why clinical research?
  • GCP for investigators
  • Shaping a research proposal
  • Ethical considerations
  • Statistical considerations in protocol writing
  • How to write a publication?

The program will be highly interactive with Q&A sessions and group discussions



REGULATIONS IN CLINICAL RESEARCH

This two day course will provide an overview of Regulatory requirements for new drug applications and marketing approvals.
It will also touch upon US, European and Indian regulatory system framework.

An outline of the course covering different topics is as follows –

  • Regulation in Clinical Research-Evolution and History
  • US Regulatory Structure
  • Investigational New Drug ,New Drug Application and Generics
  • Post Drug Approval Activities
  • Safety Reporting requirements
  • Patents
  • EMEA Organization and Function
  • EU Licensing system
  • EC Directive on Clinical trials
  • Indian Regulatory System
  • Schedule Y, Rules and regulations

The program will be highly interactive with Q&A sessions,quizzes and group discussions

Who should attend?
Regulatory managers, Clinical research personnel, and any others responsible for implementation of clinical trials.



DESIGNING CASE REPORT FORMS

This one day course will help you the understand important elements of CRF, comprehend design of case report form and a brief
look at e-CRF.

An outline of the course covering different topics is as follows –

  • CRF-A Bridge between protocol and study report
  • Benefits of a well designed CRF
  • Structure of CRF
  • Modules in a CRF
  • Electronic CRFs- the way ahead
  • eCRFs- structure and methodology
  • Softwares for eCRFs

The course will be highly interactive with group exercises of CRF designing and Q & A sessions.

Who should Attend?

Physicians, Medical advisors and Clinical research personnel responsible for implementation of clinical trials.



CLINICAL RESEARCH - FROM THEORY TO PRACTICE

The objectives of the workshop are:

  • Clear understanding of clinical research process from planning to execution
  • Hands on training in various workflows and tools used in clinical study management and monitoring
  • Apply conceptual understanding through exercises and case studies. 

Topics to be covered:

  • Overview of GCP and Indian GCP
  • Study Placement and Plan
  • Study Start-up
  • Study Management
  • Study Conduct
  • Publication Issues in a clinical study
  • Premature termination of a clinical study
  • Integrating the clinical study activities

The course will be highly interactive with many exercises and discussions.

Who should attend?

Medical Advisors, CRAs, Project Managers, all clinical research personnel from sponsor companies or CROs responsible for implementation of clinical trials and having prior exposure / training in basic GCP concepts.

This module is not suitable for Investigators and / or site staff and Data management personnel.


     
       
       
       
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