This activity already occurred and is no longer available.
Clinical Trials Network Supplemental Curriculum - Clinical Research Site Inspection: Are You Ready?
Clinical Trials Network Supplemental Curriculum - Clinical Research Site Inspection: Are You Ready?

Clinical Trials Network Supplemental Curriculum - Clinical Research Site Inspection: Are You Ready?


Release date: 05-30-11
Expiration date: 05-30-19


Authors

James Mountz, MD, PhD, is a researcher for Aposense, Ltd.

Paul Christian, CNMT, BS, PET has nothing to disclose.

John Hoffman, MD is a consultant, advisor, and has an investment interest in Contradyn, Inc.  He is also a consultant, advisor and works on a scientific study/trial for GE Healthcare.

Target Audience
Physicians and technologists

Objectives
At the completion of this activity, the participant will be able to:

1. List the various parties involved in inspecting and auditing clinical trial sites.
2. Discuss the procedures that a site should take to be ready for site inspections from monitors, the IRB, and the FDA.
3. List four items that should be done by a site prior to a monitoring visit.
4. Describe the cause and content of FDA inspections of clinical trial sites.

Continuing Education Credit Information

AMA-PRA (Physician)
SNMMI is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

SNMMI designates this enduring material for a maximum of 1.0 AMA PRA Category 1 CreditTM. Physicians should claim only credit commensurate with the extent of their participation in the activity. To receive CE credit, learners must achieve a score of 80% on the post-course assessment and complete the evaluation. 


VOICE (Technologists)
The SNMMI, through its Verification of Involvement in Continuing Education (VOICE) program, has approved this journal article for a maximum of 1 continuing education hours (CEHs). VOICE-approved credit is recognized by most licensure states and by the NMTCB and ARRT as Category A credit. In order to receive CE credit, you must first complete the activity content. When completed, take the post-test assessment. You must obtain a score of 80% to receive the CE credit. You will have no more than 3 attempts to successfully complete the post-test. California Scope: 1 Imaging(I)/Non-Imaging(NI) / Radiopharmacy(R) / Therapy(T).

Minimum system requirements

Supported Internet Browsers:
- Microsoft Internet Explorer (version 7 or higher)
- Google Chrome (latest version)
- Mozilla Firefox (latest version)
- Apple Safari (version 4 or higher)

Plug-in: Adobe Acrobat Reader (http://get.adobe.com/reader/


For questions please contact the
Education Department.
©2018 SNMMI. All rights reserved.


Type:     Internet Activity (Enduring Material)
7 Registered Users