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CITI Good Clinical Practices Course Participant Evaluation

* Questions marked with an asterisk require a response

Question Title

* 1. Please indicate your professional status.

Physician

Nurse

Allied Health Professional

Resident

Other (please specify)

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* 2. Was this learning activity fair, balanced, and free of commercial bias?

Yes

No

If not, please explain below.

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* 3. Was the format appropriate for this learning activity?

Yes

No

If not, please explain below.

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* 4. At the conclusion of this activity I am able to:

	Yes	No
Explain the expectations of sponsors and the FDA when studies are conducted according the “Good Clinical Practice” and the guidelines of the International Conference on Harmonization (ICH)	Explain the expectations of sponsors and the FDA when studies are conducted according the “Good Clinical Practice” and the guidelines of the International Conference on Harmonization (ICH) Yes	Explain the expectations of sponsors and the FDA when studies are conducted according the “Good Clinical Practice” and the guidelines of the International Conference on Harmonization (ICH) No
Identify the responsibilities of investigators in investigator-initiated studies according to FDA regulations and Good Clinical Practices	Identify the responsibilities of investigators in investigator-initiated studies according to FDA regulations and Good Clinical Practices Yes	Identify the responsibilities of investigators in investigator-initiated studies according to FDA regulations and Good Clinical Practices No
Conduct trials with investigational agents and medical devices that comply with GCP and ICH standards	Conduct trials with investigational agents and medical devices that comply with GCP and ICH standards Yes	Conduct trials with investigational agents and medical devices that comply with GCP and ICH standards No
Detect, evaluate and report serious adverse events	Detect, evaluate and report serious adverse events Yes	Detect, evaluate and report serious adverse events No
Identify the types of site visits conducted by industry sponsors and the basic requirements for each type of site visit	Identify the types of site visits conducted by industry sponsors and the basic requirements for each type of site visit Yes	Identify the types of site visits conducted by industry sponsors and the basic requirements for each type of site visit No

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* 5. Participation in this activity has: (Please check all that apply)

	Strongly Disagree	Disagree	Neither Agree nor Disagree	Agree	Strongly Agree
Increased my knowledge	Increased my knowledge Strongly Disagree	Increased my knowledge Disagree	Increased my knowledge Neither Agree nor Disagree	Increased my knowledge Agree	Increased my knowledge Strongly Agree
Improved my competence (ability to perform)	Improved my competence (ability to perform) Strongly Disagree	Improved my competence (ability to perform) Disagree	Improved my competence (ability to perform) Neither Agree nor Disagree	Improved my competence (ability to perform) Agree	Improved my competence (ability to perform) Strongly Agree
Enhanced my performance (will practice regularly in the workplace)	Enhanced my performance (will practice regularly in the workplace) Strongly Disagree	Enhanced my performance (will practice regularly in the workplace) Disagree	Enhanced my performance (will practice regularly in the workplace) Neither Agree nor Disagree	Enhanced my performance (will practice regularly in the workplace) Agree	Enhanced my performance (will practice regularly in the workplace) Strongly Agree

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* 6. This educational activity has contributed to my professional effectiveness and has improved my ability to:

	Strongly Disagree	Disagree	Neither Agree nor Disagree	Agree	Strongly Agree
Treat/manage patients	Treat/manage patients Strongly Disagree	Treat/manage patients Disagree	Treat/manage patients Neither Agree nor Disagree	Treat/manage patients Agree	Treat/manage patients Strongly Agree
Communicate with patients	Communicate with patients Strongly Disagree	Communicate with patients Disagree	Communicate with patients Neither Agree nor Disagree	Communicate with patients Agree	Communicate with patients Strongly Agree
Manage my medical practice	Manage my medical practice Strongly Disagree	Manage my medical practice Disagree	Manage my medical practice Neither Agree nor Disagree	Manage my medical practice Agree	Manage my medical practice Strongly Agree

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* 7. Overall Quality

	Poor	Fair	Average	Good	Excellent
Please provide an overall quality rating for this activity.	Please provide an overall quality rating for this activity. Poor	Please provide an overall quality rating for this activity. Fair	Please provide an overall quality rating for this activity. Average	Please provide an overall quality rating for this activity. Good	Please provide an overall quality rating for this activity. Excellent

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* 8. I intend to make the following changes as a result of participating in this learning experience:

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* 9. Comments/Suggestions