1) CRA, cCRA certification
Maximum Allowed Duration: 3 Months
Expected Effort: 12 hours/week
A Clinical Research Associate (CRA) is a professional who monitors clinical trials and research studies.
Benefits of Certified Clinical Research Associate Training & Certification:
Sponsors, CROs and other agencies involved in the implementation of clinical trials and other forms of medical research are increasingly looking for qualified individuals who have completed formal and approved training and certification in order to be able to rely on them to perform the tasks assigned to them.
CRA Training & Certification Program Structure:
Upon registering for the CRA Training and Certification program, members are granted access to the NBScience learning and certification platform. The online CRA Training & Qualification Program is a 24-hour standardized program that provides core clinical study learning. These are some of the important areas in which training is received after the qualification curriculum has been signed.
This study module, which consists of several lectures and presentations, introduces the participant to the pharmaceutical and clinical research industry.
It also allows for a thorough overview of the clinical research field and the development and developments that have led to the current clinical research environment. The Introductory Module also teaches individuals about clinical research stakeholders and the Principles of Good Clinical Practice (GCP). Technologies in the management of clinical trials are discussed in detail, and comprehensive knowledge of the major clinical research regulatory bodies that exist globally is also provided to individuals.
This program consists of multiple lectures and includes instruction on the pre-clinical development of drugs and biologics, different stages of clinical drug development, design of clinical trials and endpoints in clinical trials.
Ethics in Drug Development:
Each series, consisting of multiple lectures, discusses the concept of ethics in clinical research, the Informed Consent Process, Evidence and HIPAA, and also offers instruction at the International Conference on Harmonization (ICH).
Regulations in Clinical Research:
This module provides training in FDA regulations such as 21 CFR Parts 11, 50, 54, 56, 312,812, and 814.
Roles & Responsibilities:
It is important to identify the roles of all stakeholders in the management of clinical trials so that standards that are realistic can be established. Each section provides a comprehensive overview of the roles of clinical practitioners, sponsors, suppliers and the Institutional Review Boards (IRB).
Essential records are documents which, individually and collectively, make it possible to assess the conduct of the trial and the quality of the data generated. These records provide proof of the investigator’s compliance, support and evaluation with the Good Clinical Practice guidelines and all relevant regulatory requirements.
One of the most important and frequent inspection findings during investigator site inspections is the inadequacy of reliable and accurate source reporting. This is also the most common pitfall found during sponsor audits. To order to ensure that the results of the study are focused on reliable and relevant data, the value of good documentation practice needs to be stressed for the investigator sites. This curriculum focuses on the core principles of good data practice, offers intensive training to key areas such as source documentation, main documents, IND & NDA Requirements and the Clinical Study Report (CSR).
Each section provides an overview of clinical procedures in the start-up phase of a clinical trial. A Study Start-Up Group, vendors and sites identified and activated, procedures established for data collection and reporting, and regulatory approvals obtained shall be established from the final procedure to the first patient visit. The program offers focused instruction in areas such as feasibility evaluation, site selection, pre-study visit, site initiation, recruitment and retention of participants, the TMF (Test Master File) and budgeting of clinical trials.
Study Monitoring & Close Out:
The monitor is responsible for “surveillance the conduct of a research project.” Research monitors must have a thorough understanding of the Code of Federal Regulations, local laws, guidelines and their assigned research protocols. A major part of the reporting duties is to inform and assist sites in compliance with FDA and other local and international regulations and/or recommendations, while also helping them meet the requirements of specific research studies. Monitors act both as communication channels between sites and sponsors and as supervisors for individual research projects. This program offers extensive training in areas such as regular site monitoring, CRF analysis and source data verification, product transparency and compliance, site closure, writing accurate monitoring reports and follow-up visit letters, and record archiving and maintenance.
One of the CRA’s most important priorities is to ensure that clinical inspectors are fully aware of and comply with their responsibility for reporting adverse events. To do it, the CRA must often notify investigators of the criteria for adverse event reporting. As a result, the CRA must be aware of both the regulatory and sponsor-specific criteria for reporting significant and non-serious adverse events in clinical trials. It requires the proper use and completion of adverse event forms and criteria and conditions for reporting adverse events that may go further than the regulatory requirements. Each program offers instruction in the identification and monitoring of adverse and serious adverse events in clinical trials.
Role of Quality Assurance & Data Management:
Each program offers relevant training in quality assurance (QA) audits and testing, electronic data and signatures, information management and biostatistics..
2) GCP course for Investigators and CRAs
3) GCP course for Auditors
(see below or for detailed information click here)
GCP training curriculum
(1) GCP training
ICH-GCP international guidelines
1.2 What is GCP
1.3 New GCP Guide
1.4 The Principles of ICH GCP
1.5 Some General Point
1.6 Documentation and Version Control
1.7 Quality Assurance
2: Competent Authorities (CA) and Independent Ethics Committee (IE)
2.1 Responsibilities of the CA
2.2 Responsibility of the IE
2.3 Subject Informed Consent Forms (ICF)
2.4 Composition, Functions, Operations, Procedures and Record
3.1 Investigator Responsibilities
3.2 Investigator Qualifications and Agreements
3.3 Adequate Resource
3.4 Medical Care of Trial Subjects
3.5 Communication with IRB/IE
3.6 Compliance with the Protocol
3.7 Investigational Medicinal Produc
3.8 Randomization Procedures and Un-blinding
3.9 Informed Consent of Trial Subject
3.10 Records and Reports
3.11 Premature Termination or Suspension of a Trial
3.12 Progress Reports and Final Report(s) by Investigators
3.14 Considerations for the use of electronic systems in clinical trial management
3.15 Updated information on electronic records and use of EMRs in clinical research.
4: Sponsor’s Responsibilities
4.1 Quality Assurance and Quality Control
4.2 Contract Research Organization
4.3 Trial Design
4.4 Trial Management, Data Handling and Record Keeping
4.5 Investigator Selection
4.7 Notification/ Submission to Regulatory Authoritie
4.8 Gaining CA approval in the
4.9 Confirmation of Review by IRB
4.10 Information on IM
4.11 Manufacturing, Packaging, Labelling and Coding Investigational Product
4.12 Supplying and Handling Investigational Product
4.13 Record Access
4.14 Audit and Inspection
4.16 Premature Termination or Suspension of a Trial
4.17 Clinical Trial/Study Report
4.18 Multicentre Trial
5: Monitor’s Responsibilities
5.1 About this Chapter
6: Safety & Adverse Event Reporting
6.1 Adverse Drug Reaction Reporting
7: Clinical Trial Protocol and Amendment
7.1 Trial Objectives and Purpose
7.2 Trial Design
7.3 Selection and Withdrawal of Subject
7.4 Treatment of Subject
7.5 Assessment of Efficacy
7.6 Assessment of Safety
7.8 Direct Access to Source Data/Documents
7.10 Financing and Insurance
7.11 Publication Policy
8: Investigator Brochure
9: Essential Documents
9.2 Documents to be Present Pre-Study
9.3 Documents to be Added During the Study
9.4 Documents to be Added Post-Study
10.1 Practical examples of good (and poor!) practice in relation to conducting clinical trial
ICH-GCP (E6-R2) international guidelines