Beth Baseler, MS
Director, CMRP, SAIC-Frederick, Inc.
Director, CMRP, SAIC-Frederick, Inc.
SERVICES AVAILABLE THROUGH THE CMRP ARE AS FOLLOWS:
— Provides comprehensive clinical trials monitoring/management and regulatory support encompassing clinical monitoring, IND (investigational new drug)
management, regulatory support, as well as other operational support.
— Maintains regulatory surveillance over clinical trials to assure that trials are conducted in accordance with Department of Health and Human Services (DHHS)/FDA/NIH regulations and International Conference on Harmonization/Good Clinical Practices (ICH GCP) guidelines.
— Develops, assembles, maintains, and submits to sponsor IND applications and interim/annual reports to FDA. These include regulatory guidance, assisting in determining if an IND is needed: IND Application Review Document for New Protocols; consultation, preparation, and submission of IND applications - Investigator's Brochure, "Protocol Review," "Informed Consent Form Review," and Pre-IND meetings with FDA; IND maintenance - maintain IND through IND amendments, annual reports, IND safety reports, and communication links with the FDA.
— Reviews adverse event reports and prepares safety reports by providing instruction and guidance to staff, and preparing and submitting IND safety reports for sponsored
INDs; implementing a dedicated safety fax and phone line; developing uniform SAE reporting forms.
— Acts as a liaison for regulatory issues with FDA, pharmaceutical industry, and Office for Human Research Protection during the initiation and conduct of a clinical trial.
— Develops training programs in the principles of good clinical practices and the regulations pertaining to the Standards of Clinical Research for clinical research personnel.
— Provides pre-Institutional Review Board (IRB) protocol and informed consent review to include: protocol templates based on CC Protomechanics Guide, review protocol
and consent for adherence to Code of Federal Regulations (CFR) and ICH/GCP, evaluation of IND requirements, recommendations regarding monitoring intramural Data
and Safety Monitoring Board (DSMB) plan, and evaluation of case report form needs.
— Provides clinical research trials monitoring by developing guidelines on monitoring requirements; providing investigator study binders for new protocols, study manuals
for study staff and protocol and informed consent review prior to submission of the IRB application/approval; initiating protocol monitoring to protect the well-being
of human subjects; reporting accurate trial data (safety/efficacy and adherence to clinical protocol), compliance with regulatory authorities (NIH/DHHS and/or FDA), and
compliance with ICH/GCP; meeting with the PI to conduct and review/outline monitoring plan and discuss study initiation visits, routine monitoring visits, study close-out
visits, and tools to assist study staff with conducting the trial.
— Provides clinical research nurses, protocol nurse coordinators, and clinical assistants to support various NCI clinics.
— Manages clinical operations and provides scientific administration to oversee establishment of subcontracts.
— Provides comprehensive clinical trials monitoring/management and regulatory support encompassing clinical monitoring, IND (investigational new drug)
management, regulatory support, as well as other operational support.
— Maintains regulatory surveillance over clinical trials to assure that trials are conducted in accordance with Department of Health and Human Services (DHHS)/FDA/NIH regulations and International Conference on Harmonization/Good Clinical Practices (ICH GCP) guidelines.
— Develops, assembles, maintains, and submits to sponsor IND applications and interim/annual reports to FDA. These include regulatory guidance, assisting in determining if an IND is needed: IND Application Review Document for New Protocols; consultation, preparation, and submission of IND applications - Investigator's Brochure, "Protocol Review," "Informed Consent Form Review," and Pre-IND meetings with FDA; IND maintenance - maintain IND through IND amendments, annual reports, IND safety reports, and communication links with the FDA.
— Reviews adverse event reports and prepares safety reports by providing instruction and guidance to staff, and preparing and submitting IND safety reports for sponsored
INDs; implementing a dedicated safety fax and phone line; developing uniform SAE reporting forms.
— Acts as a liaison for regulatory issues with FDA, pharmaceutical industry, and Office for Human Research Protection during the initiation and conduct of a clinical trial.
— Develops training programs in the principles of good clinical practices and the regulations pertaining to the Standards of Clinical Research for clinical research personnel.
— Provides pre-Institutional Review Board (IRB) protocol and informed consent review to include: protocol templates based on CC Protomechanics Guide, review protocol
and consent for adherence to Code of Federal Regulations (CFR) and ICH/GCP, evaluation of IND requirements, recommendations regarding monitoring intramural Data
and Safety Monitoring Board (DSMB) plan, and evaluation of case report form needs.
— Provides clinical research trials monitoring by developing guidelines on monitoring requirements; providing investigator study binders for new protocols, study manuals
for study staff and protocol and informed consent review prior to submission of the IRB application/approval; initiating protocol monitoring to protect the well-being
of human subjects; reporting accurate trial data (safety/efficacy and adherence to clinical protocol), compliance with regulatory authorities (NIH/DHHS and/or FDA), and
compliance with ICH/GCP; meeting with the PI to conduct and review/outline monitoring plan and discuss study initiation visits, routine monitoring visits, study close-out
visits, and tools to assist study staff with conducting the trial.
— Provides clinical research nurses, protocol nurse coordinators, and clinical assistants to support various NCI clinics.
— Manages clinical operations and provides scientific administration to oversee establishment of subcontracts.
SERVICES