TRAINING SERVICES

High-quality studies require proven, flexible services that support the entire research lifecycle

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TRAINING SERVICES

The CRO is also thrilled to work with your organization to bring professional development and capacity building programming to your team. Part of courses offered at The CRO include our pre-developed courses, however, we can create also create/customize other courses in a wide variety of Clinical Research related topics to suit our client needs. All our courses combine didactic/classroom lectures with actual/practical sessions in a simulated research clinic/research setting. Some of our existing capacity building programs and services include (but not limited to) the following:

  • Human Research Ethics (RE) Training/Human Subjects Protection (HSP)
  • Good Clinical Practices (GCP) Training
  • Data Management Training
  • Scientific/Manuscript Writing Training
  • Human Research Ethics (RE) Training

    This one-day program provides training on Research Ethics (RE)/HSP. Research Ethics training is recommended for all personnel conducting research in human participants and is necessary to ensure proper understanding of the issues surrounding the participation of human subjects in research studies. The goals of the CRO RE program include:

  • Reviewing of the Principles of Research Ethics;
  • Understanding of the Foundations of Research Ethics;
  • Understanding of issues around Responsible Conduct of Research (including an in-depth understanding of Informed Consent, Informed Consent as a Process and Essential Elements of Informed Consent);
  • Understanding of issues around Supervision of Research (Including regulatory obligations of Institutional Review Boards [IRBs]/Ethics Committees [ECs].
  • Good Clinical Practices (GCP) Training

    This two-day program provides training to the site staff on Good Clinical Practice (GCP). GCP is probably the most accepted and widely known international ethical and scientific quality standard for designing, conducting, recording, and reporting studies that involve the participation of human subjects. GCP training is recommended for all personnel conducting human subject research. Compliance with this standard provides assurance that the rights, safety and well-being of trial subjects are protected, and that the data are credible. The goals of the CRO GCP program include:

  • Understanding the background and history which led to the GCP guideline;
  • Defining and understanding the roles and responsibilities of Ethics Committees (ECs), investigators, and sponsors as they relate to the protection of human subjects in research, and the quality and conduct of research studies;
  • Understanding how to incorporate GCP into clinical research programs (particularly in the role of the site investigator)
  • Ensuring scientific quality and ethical integrity
  • Understanding how to implement studies so as to ensure that the collected data and supporting documentation are accurate, reliable and can be verified.
  • Data Management Training

    The two-day program provides staff with an understanding the principles and practices required to ensure that the research data are of high quality prior to analysis. The Program Goals include:

  • Understanding and discussing the key research data management principles;
  • Understanding the regulatory framework impacting on research data management;
  • Implementing the processes and steps required to undertake a data management project from start to finish;
  • Analysing the data requirements and building a database to hold and manipulate research data;
  • Developing and specifying how research data are to be checked and confirmed;
  • Resourcing and supervising a data management project;
  • Coding and categorising research data in preparation for analysis and discussion of common problems and solutions arising during the data management process.
  • Scientific/Manuscript Writing Training

    The two-day program enables staff to understand how research and Clinical Trials are reported using best practice, and to provide them with the skills for reporting and publishing data from a research project: The Program Goals include:

  • Description of the key features that should appear in a research report;
  • Understanding the reasons why certain features of research need to be reported, and the effect of these on potential bias in the results
  • Description and understanding of the process required to produce a scientific publication;
  • Explanation of the processes necessary to do a high-quality systematic review;
  • Understanding how to search literature for relevant publications;
  • Understanding the graphical and statistical presentation of results of research and use of conventional databases (such as the Cochrane Databases) to find relevant researches and systematic reviews.
  • Depending on the clients’ requirements, these training services are offered either as part of the research projects that we are contracted to manage or as separate/stand-alone projects. We offer services in all aspects of training from planning to actual delivery of the events which include Scoping, Design/Development and Implementation of each of the programs outlined above.

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