Know Specific knowledge about the concept of deviations and violation of protocols and its implications.
Why Should You Attend:
Federal regulations require that no changes be made in the research protocols without the approval of the IRB, except when necessary to eliminate apparent immediate hazards to humans. There should be a solid knowledge of the protocol approved by the IRB to avoid this potential security risk of the patient clinical study. Misuse or tampering with records for the protocol should always be, primarily because of its quantity or types that cause bias in the data of the study and also impact the quality of survey data for analysis. Moreover it is very important establish the involved team roles to ensure safety for all participating subjects in the conduct of the research follow the IRB-approved research protocol.
This web training intends to provide specific knowledge about the concept of deviations and violation of protocols and also its implications; It will also be discussed the measures to minimize the risk of the integrity of the protocol and regulatory aspects implicated for the application of a new drug. It will also be discussed the measures to minimize the risk of the integrity of the protocol and regulatory aspects implicated for the application of a new drug.
Areas Covered in the seminar:
- Concepts of safety and welfare of research participants.
- Description of the rights of research participants.
- Integrity of the study design.
- Informed Consent process.
- Classification and examples of Protocol Deviations/Violations and definitions of key terms.
- Examples of major and minor deviations, violations and exceptions.
- Overview of specific reporting requirements.
Who will benefit:
This webinar intends to provide expertise regarding clinical data for any member involved in clinical trials development among Pharmaceutical Industries
- CROs
- Vendors
- Study Sites
- Steering Committees
- Consultants
- Regulatory agencies
Instructor Profile:
Ingrid Koster, Epidemiologist, has worked in Clinical Research operations as Investigator and also as sponsor in the Pharmaceutical Industries along almost 15 years in Latin America. Ms Koster combines her background and current position in Public Health with her expertise in Research and Development within Pharmaceutical Industries to bring to us not only experiences in Clinical Trials management in several Therapeutic Areas but important insights to improve knowledge and perception for the major points regarding Clinical Research development.
