The August 13, 2013 lecture - PI and CRC Responsibility & Oversight is not available via mediasite for GCP credit.

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1 2013 Responsible Conduct in Research Lecture Series How to get 8 Hours of CME/GCP Credit Physicians can receive CME credit for these, and everyone receives GCP Education credit towards the GCP Education requirements. The Mediasite presentations give you the actual video of the person giving the lecture along with the slides presented in the same sequence and timing as the original lectures. If you click on the slide portion of the Mediasite presentation, the slide will open in a new window and you can print out selected slides if you find them helpful for future reference. After viewing the 2013 RCR Lectures you choose, answer the CME/GCP questions on the answer sheet. When you finish, fax the answer sheet with your attestation to the IRB Office at x The answer sheets for 2013 RCR lectures must be faxed within 3 years of the lecture to obtain CME credit for physicians; GCP credit may be obtained as long as the lectures remain on Mediasite. To receive credit, you must answer at least 75% of the questions correctly. You cannot receive credit from these Mediasite presentations if you already received it from the live presentations Responsible Conduct in Research Lecture Series (held in Monroe Hall on 2nd Tuesdays of the month) Maximum credit 8.0 hours (1.0 hour per lecture; 5 lectures) Accreditation The Ochsner Clinic Foundation is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Designation The Ochsner Clinic Foundation designates this enduring material for a maximum of 8 AMA PRA Category 1 Credits. Physicians should claim only credit commensurate with the extent of their participation in the activity. CME credit opportunity EXPIRES 3 years from the date of the lecture To view the lectures, click here. and locate the 2013 RCR lectures under the IRB tab See CME questions below PLEASE NOTE: The August 13, 2013 lecture - PI and CRC Responsibility & Oversight is not available via mediasite for GCP credit.

2 2013 Responsible Conduct of Research Lecture #1 January 8th Conducting Investigator Initiated Trials Indranill Basu Ray, MD 1. A B 2. A B 1. A Sponsor Investigator means an individual who both initiates and conducts an investigation and under whose direction the investigational drug, device or procedure is administered. 2. Through the process of informed consent, prospective subjects are given the opportunity to make autonomous decisions about participating in research. 3. Research misconduct is fabrication, falsification, or plagiarism in proposing, performing or reviewing research or reporting research results. 4. External monitoring boards such as a DSMB ensure, to the extent possible, the safety of study participants and help ensure study integrity.

3 2013 Responsible Conduct of Research Lecture #2 April 9th Enhancing the Informed Consent Process Stephanie Gaudreau, CIP 1. A B C D 2. A B C D 1. The basic elements of the consent process include: a. Full disclosure of the nature of the research and the subject s participation b. Adequate comprehension on the part of the potential subjects. c. The subject s voluntary choice to participate. d. All of the above. 2. Which of the following can give consent? a. Minors b. Incompetent adults c. Legally competent adults d. None of the above 3. IRB s have the authority to waive some or all of the requirements for consent and/or documentation of consent provided the research meets the criteria in the regulations. 4. Enhancements to the consent process, including videos or comprehension tests, do not need to be reviewed by the IRB.

4 2013 Responsible Conduct of Research Lecture #3 July 9th Ethics on Research Specimens: Who Has Rights to Research Specimens? Don McKinney, JD 1. A B 2. A B 1. Under the current state law, a research subject does not retain any right to the financial benefits arising from patents and commercialized products derived from his/her tissue samples. 2. Informed consent may not be required for tissue collection if the IRB determines the information involves no identification of the research participant. 5. The informed consent document should describe the status of donated tissues in the event of withdrawal from a research study. 6. Informed consent documents can contain exculpatory language.

5 2013 Responsible Conduct of Research Lecture #4 October 8th Best Practices for Responsible Investigators The Ochsner Research Quality Improvement Program Stephanie Gaudreau, CIP 1. A B C D 2. A B C D C D 1. Commitments from a Principal Investigator on FDA Form 1572 include a. to personally conduct or supervise the investigation b. follow the protocol c. ensure all persons assisting with the study are informed of their obligations d. All of the above. 2. Adequate training as defined by the FDA ensures all research study staff: a. are familiar with the study protocol b. are aware of regulatory requirements c. are competent to perform delegated tasks d. All of the above 3. Adequate PI supervision as defined by the FDA includes: a. routine meetings with staff b. procedures for correcting problems c. routine meetings with Sponsor s monitors d. All of the above 4. Insufficient PI involvement in the conduct of a research trial is a common risk factor for noncompliance.

6 2013 Responsible Conduct of Research Lecture #5 November 12th Subject Injury in Research Rachel Rand, JD 1. A B 2. A B C D 1. Subject injury is defined as injury, illness, adverse event or side effect resulting from the study subject s participation in the research. 2. Injury can be caused by the investigational item (drug, device), placebo, or any procedure, test, treatment required by the protocol. 3. There is currently no current US law requiring payment for subject injury expenses. 4. Current US law states that for studies involving more than minimal risk, the consent form must indicate the following a. an explanation as to whether any compensation is available b. an explanation as to whether any medical treatments are available if injury occurs c. an explanation of whom to contact in the event of research related injury d. All of the above