Educational Objectives

The Physician will be able to identify:

• Basic concepts of clinical trials
• The parts and organization of a clinical trial
• Reasons why Hispanics do not participate in clinical trials
• Basic concepts of budget and contracts in a clinical trial
• Benefits for the physician, patient, and Hispanic community of a clinical trial

Target Audience: Hispanic physicians and physicians who serve the Hispanic community.

ICPS designates this educational activity for a maximum of 6 hours of AMA PRA Category 1 Credit(s)™. Physicians should claim credit commensurate with the extent of their participation in the activity.

Educational Objectives

• Review the Types and Phases of Clinical Trials
• Understand types and phases of clinical trials, the clinical trial team and role of the CRO / SMO
• Understand the benefits to physicians and patients for participating in clinical trials
• Understand the required monitoring visits
• Become familiar with the NHRN SOPs relating to duties and responsibilities of the NHRN Research Team and monitoring visits

Target Audience: Physicians who completed the ICPS Clinical Trial Basic Course.

ICPS designates this educational activity for a maximum of 3 hours of AMA PRA Category 1 Credit(s)™. Physicians should claim credit commensurate with the extent of their participation in the activity.

Educational Objectives

• Understand the Responsibilities of the Site Research Team
• Understand the commitments made by a principal investigator by signing the FDA Form 1572 - Statement of the Investigator

Target Audience: Physicians who completed the ICPS Clinical Trial Basic Course.

ICPS designates this educational activity for a maximum of 2 hours of AMA PRA Category 1 Credit(s)™. Physicians should claim credit commensurate with the extent of their participation in the activity.

Educational Objectives

• Understand the steps for fulfilling the regulatory, medical, and ethical requirements for assessing the feasibility of implementing a protocol
• Understand the steps followed by research sites from the time the site is selected for a clinical study until recruitment of subjects begin
• Understand the process and documentation required for informed consent.
• Understand the steps for fulfilling the regulatory and ethical requirements for developing the informed consent document and for appropriately obtaining the subject’s informed consent.
• Understand the steps for fulfilling the regulatory and clinical requirements involved in subject recruitment and selection.

Target Audience: Physicians who completed the ICPS Clinical Trial Basic Course.

ICPS designates this educational activity for a maximum of 3 hours of AMA PRA Category 1 Credit(s)™. Physicians should claim credit commensurate with the extent of their participation in the activity.

Educational Objectives

• Understand how a site communicates with the IRB throughout the research process in order to ensure compliance with the regulations and to protect the safety and well-being of study subjects.
• Understand the steps for fulfilling all regulatory, and clinical requirements for collecting, filing and storing study-related documents and records.

Target Audience: Physicians who completed the ICPS Clinical Trial Basic Course.

ICPS designates this educational activity for a maximum of 3 hours of AMA PRA Category 1 Credit(s)™. Physicians should claim credit commensurate with the extent of their participation in the activity.

Educational Objectives

• Understand the steps for fulfilling the regulatory and clinical requirements to ensure adherence to study procedures for the evaluation of a subject’s response to the investigational article.
• Understand the steps NHRN clinical research teams follow to fulfill the regulatory and clinical requirements for adverse event reporting

Target Audience: Physicians who completed the ICPS Clinical Trial Basic Course.

ICPS designates this educational activity for a maximum of 3 hours of AMA PRA Category 1 Credit(s)™. Physicians should claim credit commensurate with the extent of their participation in the activity.

Educational Objectives

• Understand the various ways of communicating with the CRO as all regulatory, medical, and ethical requirements are fulfilled, including telephone and written interactions.
• Understand the processes at NHRN investigative sites for the receipt, storage, dispensing, reconciliation, and return or authorized destruction of the investigational drug (study drug).
• Understand the steps which must be taken to ensure that subject personal health information is kept confidential and access to such information is limited to authorized research staff for approved purposes only.
• Understand the steps which must be taken to ensure that subject personal health information is controlled and access to such information is limited to authorized research staff for approved purposes only Understand the steps for fulfilling the regulatory and clinical requirements involved in specimen collection and handling.
• Understand the processes followed at investigative sites for the collection of clinical research data, transcription of the data to case report forms (CRFs), and the management of the data, including procedures for: quality control, data query resolution, and record retention and archiving.
• Understand the preparation and maintenance of the written procedures that research team members must follow to ensure compliance with all Food and Drug Administration (FDA) regulations and guidelines and polices of the CRO at investigative sites.

Target Audience: Physicians who completed the ICPS Clinical Trial Basic Course.

ICPS designates this educational activity for a maximum of 5 hours of AMA PRA Category 1 Credit(s)™. Physicians should claim credit commensurate with the extent of their participation in the activity.