International Institute of Technology and Applications

A Clinical Research Associate, is also a professional widely known as a Monitor, this individual is trained to conduct clinical trials and manage the process. Clinical trialsare usually implemented by physicians at hospitals, clinics, or physicians’ offices. The CRA is a professional trained to oversee the initiation, progress, and conduct of the clinical trialsand ensure the scientific integrity of the data collected, and the protection of the safety, rights, well-being of the study subjects and these subjects are human beings.

• Monitoring that the physician sticks tenaciously to Good Clinical Practices and the study protocol.
• Performing and ensuring study drug accountability;
• Verifying and validating the documentation of the informed consent process for each study subject;
• Ensuring strictly that non-serious and serious adverse experiences are properly documented and reported.
• Reviewing and ensuring the completeness and accuracy of the case report form against the subject's medical record;
• Ensuring strictly the filing and maintenance of the required regulatory documents.

The CRA usually has a science and or health care background (e.g. Bachelor's, Master’s, or a Ph.D. in a science, nurse, medical technologist, or physical therapist). The CRA is most frequently employed by a pharmaceutical company, contract research organization, academic institution, or site management organization. A CRA usually work either in-house or in the field, requiring 50-70% travel. As a field monitor, CRA will visit multiple sites and interacts with the study coordinator and the investigator conducting the trial.

Pharmaceutical companies are presently fast tracking or crashing the development time necessary for their products to receive FDA approval, so that the products can go into the market fast. Monitoring of a clinical trial is the first step in identifying potential data differences, discrepancies and regulatory issues. Insufficient and or inadequate monitoring can jeopardize the safety of the study participant and/or is a leading factor to the delay in gaining drug approval. Well-trained and knowledgeable CRAs play vital roles in protecting the study participants and help to reduce the pace of time between drug development and marketing approval. The demand for well-trained CRAs will continue to grow, because their supply is highly limited.

Target Audience:

• Clinical Research Professionals in the Drug, Device andBiologic Industry.
• Clinical Research Analyst Certification
• 140 Hour CRA Certificate Program Course Structure

• Describe the medical product pathwaycommencing with discovery and ending with marketing approval.
• Identify all the GCP obligations relating to protecting the rights of study subjects.
• Distinguish all the different roles and GCP obligations between the investigate, Sponsor and IRB
• Adequately explain the ‘ideal’ elements employed in coordinating a clinical trial
• Demonstrate sufficiently the ability to perform monitoring and coordinating activities and effect the detection of deficiencies.
• Selectand apply different problem-solving techniques in resolving GCP deficiencies.

Requirements

The requirements for applicants that plan to undertake the Clinical Research Associate Training Program are any of the followings: Bachelor’s, Master’s, or a Ph.D. in a Science or Allied Health Field OR Healthcare Professionals (e.g. RN, PA, MD, PT, RPh, PharmD, or Medical Technologist

Criteria for Course Completion:

• Comprehensive cumulative core knowledge exam, validating the CRA education, based on Chapters 1 through 7 with a minimum score of at least 70%.
• Monitoring competency exam, which is measured by monitoring a subject’s case history and the investigator study file identifying at least 80% deficiencies.
• GCP Regulatory/ICH Guideline exam with a minimum score of at least 70%.

The candidate will be given a certificate of completion of the Clinical Research Professional program, in addition to another certificate of recognition for passing the GCP Regulatory/ICH Guideline exam. The CRA program curriculum

• Food and Drug Administration Past and Present
• Food and Drug Administration establishment details.
• The History of the Legislation and Regulations that govern the Clinical Research Process.
• The History of the Legislation and Regulations that Protect the Rights, Safety, and well-being of the Human Subjects.

Overview of Medicinal Product

• Research and Development
• Drug Discovery and Pre-Clinical Research details.
• The Clinical Research and New Drug Application Approval Process details.
• The Biologics Research, Development, and Licensing Process details.
• Medical Device Research, Development, and Marketing Approval/ Clearance details.

Good Clinical Practice (GCP)

• Investigational New Drug Application - 21 CFR 312: Sponsor’s Obligations.
• Investigational New Drug Application - 21 CFR 312: Investigator’s Obligations.
• Investigational Device Exemption - 21CFR 812.
• Institutional Review Boards - 21 CFR 56.
• Protection of Human Subjects - 21 CFR 50.
• Financial Disclosure 21 CFR 54.

International Conference of Harmonization

• The detailed History of the International Conference of Harmonization.
• The ICH Good Clinical Practices Consolidated Guideline (E6).
• The ICH Clinical Safety Data Guideline (E2).

Clinical Trial Development

• Protocol Design and Development
• Case Report Form Design and Development
• Principals of Data Management and the Query Resolution Process details
• The Study Types Providing Expanded Access to Investigational Products details

Clinical Trial Management Investigator Site Perspective: Coordinating a Clinical Trial at the Site

• Essentials of detail Source Documentation.
• Maintaining and Managing Essential Documents and promptly too.
• Recording and Reporting Non-Serious and Serious Adverse Events and timely too.

Monitoring Obligations and Methods

• Monitoring Role and Responsibilities According to the FDA Guideline and that of the ICH GCP (E6) Guideline.
• Monitoring Responsibilities: Type of Monitoring Visits, Monitoring Activities - Pre-Visit, On-Site, and Post Visit.
• IITA Step Monitoring Method: Implementing a Systematic Monitoring Method to Effectively Monitor a Multi-Center Trial.
• Problem Solving and Trouble Shooting GCP / ICH Issues.
• Writing Strategic Monitoring Reports and Follow-Up Visit Letters.
• Electronic Data Capture and 21 CFR 11.

Hand-on practice sessions

Monitoring is an essential part of clinical research and requires a systematic approach, involving the standardization of the monitoring activities, yielding quality data within an efficient timeframe. IITA provides 2 weeks of exposure to monitoring, applying our golden "4 Steps Quality Monitoring Method (QMM)". We train on "how to" monitor, "how to" write an efficient report, "how to" interact with sites on a regular basis and with difficult issues and “how to” ensure high standard quality audit.

The "Hands-On" was crafted to expose the participants to different therapeutic areas, monitoring plans, source documents, Case Report Forms (CRFs), and Standard Operating Procedure (SOP) Requirements. Students receive a protocol, monitoring plan, and CRF completion guideline.

During week one, a Study involving three subjects and the Investigator file is discussed and monitored. During week two, a study involving two subjects and the Investigator file is also discussed and monitored. Each case study is designed using sophisticated GCP deficiencies. The level of sophistication and difficulty increases with each subject, enabling the student to gain exposure to a wide range of GCP issues.

The monitoring activities are followed by reviews and discussions, during which, deficiencies are detected. Using IITA's "Issue, Action, and Follow-up" report writing technique, ICH GCP action plans are presented to resolve the deficiencies and prevent their reoccurrence in the future. The content, strategies and essence of writing professional and effective reports will be well emphasized throughout the two week training session. Students receive report writing guidelines and are made to prepare a written report for review by their instructors.

IITA experienced and professional instructorsactively monitor and manage research studies, viz. sharing with the students their commitments, experiences, and passion for clinical research, they thereby bring real world knowledge and issues into the classroom. They also ensure:

• Comprehensive review of the Part 1;
• Case studies simulating all CRA activities;
• Course examinations and pre-exam reviews;
• Resume evaluation and career guidance;

Prerequisite for the hand-on 2 weeks class: Part 1 Education.

Résumé and Job Placement

• Students are drilled with a résumé writing guideline.
• Students get their résumé evaluated by experienced Clinical Research Professionals.
• Successful graduates have their résumé forwarded to hundreds of potential employers (pharmaceutical companies, contract research organizations, academic institutions, and research sites).
• Résumés would be posted on IITA’s website for free access to employers.