888.529.5929 / 8:30 a.m. to 7:30 p.m. / U.S. Eastern Time / Monday - Friday. These device courses cover FDA regulation as well as International Organization for Standardization Guidelines ISO 14155:2011. Language Availability: English, Chinese, French, German, Spanish, Korean, Finnish, Suggested Audiences: The sponsor will contact the appropriate registration authority (PDF) who will complete the OCIO non-MUSC application for a NetID to provision and deliver the NetID. GCP course is offered in three versions (devices, drugs, social-behavioral research). }���t��vJޠ�����ꤞ���"���+=!u� ��QOl���T�ӥ�F=�Z��=R]C���)�_��g.X$i��̷��Wz�[ڢa $���1��p���K���a�,�e��ǤX�I ��a g=7��^�y��Б>Y#��dž;���e��-��7�N6.e���ݡ�u��re�gx����m�]���=��1ޮB���2����3��0�,Q��c�*�u��)q�? Log In to CITI … 2. Please also note that organizations and learners that wish to utilize these mutually recognized GCP courses in keeping with the minimum criteria must designate all available modules as “Required.”. CITI Program offers several GCP courses that are considered acceptable by many leading organizations to meet their training needs per NIH. CITI GCP Course Prep. If you complete your GCP course after the effective date for version 2, your Completion Report will indicate that on the Transcript Report (it will include the course name and which version you completed). Home Browse. The Medical University of South Carolina is dedicated to engaging community members in all aspects of the research process. Initial and continuing education (every 3 years) are required as explained below. Rev. The CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Biologics Provides an introduction to the course and a link to the Belmont Report. ����v�4& -Ax+Au��:����ۻ���y/eO����v\�I���p �,4�'�>�C���� ��X�E�b�R�9��tcK�N�Bl�!��n�J����.C�jga��� A�A7pz c[�KP�����X[��� ��0@���ꠔuP���uջy����e6��6��B%J��N�/�k*x ����9�Df8�e�)S7��ZV)����eU%� &�-�i� �2��m���Y�����y�<7�2ƥ��8�}����'uU����-�ꖔ���هi�~I�TEV�)����\��Sfo�)3K�2k��l��Z�m{�=�u�DVX�f�:rS�)��i#���F�e�|�Vdؐ���:�~���w��Pf CITI Program GCP training is used by over 1,500 institutions - (including many leading hospitals, academic medical centers, universities, and healthcare companies) - to meet their GCP training needs. 1 s.h. Professor Heather A. Boger, Ph.D. Using CITI Program refresher course options to provide retraining means that the learner will not be completing the same course every time. Professor and Interim Director, Center for Biomedical Imaging Thomas Jhou, Ph.D. Assistant Professor … The university uses the Collaborative Institutional Training Initiative (CITI) web-based human research course to satisfy the requirement for MUSC researchers for training in human research subjects protection. Version 1 refers to the ICH E6(R1) minimum criteria that was used to attest the course for mutual recognition to TransCelerate BioPharma. Modules consist of detailed content, images, supplemental materials (such as case studies), and a quiz. Professor and Chair, William E. Murray SmartState Endowed Chair of Excellence Maria de Fatima Falangola, M.D., Ph.D. Assistant Professor Tatyana Gudz, Ph.D. South Carolina Tobacco Research Group (SCTRIG) Description: Tobacco research at MUSC is coordinated through a collaborative group of investigators within SC TRIG.Formed in December 2010, SC TRIG is an interest group composed of experts with research interests in nicotine dependence, smoking cessation, and tobacco control. *�Ba �ɱ�^ yW� endstream endobj 141 0 obj <>stream If you are involved in the conduct of an NIH-funded clinical trial, you are required to … By using our Sites, you consent to the use of these technologies. The CITI Good Clinical Practice Course for Clinical Investigations of Devices Provides an introduction to the course and a link to the Belmont Report. NIH Good Clinical Practice Offered through the UC Davis Learning Management System, this training focuses on GCP for social and behavioral clinical trials. \2��u*����y{u-߯�n�~K9kˊ���� �^�]���f The National Institutes of Health (NIH)* requires completion of GCP training that demonstrates that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording, and reporting trials that involve human research participants. The Trusted Standard in Research, Ethics, and Compliance Training The Collaborative Institutional Training Initiative (CITI Program) is dedicated to serving the training needs of colleges and universities, healthcare institutions, technology and research organizations, and governmental agencies, as they foster integrity and professional advancement of their learners. ����O�Pc��֘��\ ���M�bc��t ۭȢ3��K�&N�`��~�`SGGG7��`66 [�_��}�n��x6m� �o� There are a number of modules available on the CITI website: (1) CITI Good Clinical Practice Course (ID: 30156), (2) GCP – Social and Behavioral Research Best Practice for Clinical Research (ID: 153898) and (3) Buenas Practicas Clínicas (Módulos en Español) (ID: 59514). Informatics and Data Managemen. In the past this particular CITI training module has only been optional at MUSC. Please note MUSC has confirmed with NIH that completion of MUSC’s CITI training course/module entitled “Good Clinical Practice and ICH” will satisfy this new requirement. @Bn��y$D�2���� ��L�� +���T� � bhr endstream endobj startxref 0 %%EOF 185 0 obj <>stream These care models are organized into Integrated Centers of Clinical Excellence (ICCE) with a ICCE Chief overseeing the achievement of these goals. GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) Course, GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) Course, GCP for Clinical Investigations of Devices Course, GCP – Social and Behavioral Research Best Practices for Clinical Research, GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus), GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus). GCP content is suitable for research teams involved in clinical trials of drugs, biologics, and devices, as well as those involved in behavioral intervention and social science research studies. Flashcards. Available on the Education and Training Tab of the eIRB; eIRB States Chart - definitions of the states of activities in the eIRB system, the personnel roles that can make changes when an activity is in a certain state and the types of eIRB forms that will have this the state. These courses were written and peer-reviewed by experts. This NIH policy is effective as of January 1, 2017. Narayan Bhat, Ph.D. GCP provides research-specific, peer-reviewed training written by GCP experts. Page 1 . 0�u40�et0 PLAY. The MUSC College of Nursing has a long and distinguished history of more than 136 years preparing the finest professional nurses who care, cure, and create new knowledge in improving the health of individuals, families, and communities. IRB Members, Clinical Research Coordinators, Clinical Research Organizations (CROs), Researchers, Investigators, Key Study Personnel, Principal Investigators, Research Nurses, Research Staff, Sponsors, Study Coordinators. Along with a summary description of content, learners can view type and number of credits available, costs and other relevant CME information attached to each. Other GCP courses cover drug, device, and biologic-related studies. The NIH requires completion of GCP training that demonstrates that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording, and reporting trials that involve human research participants. Associate Professor Jens Jensen, Ph.D. Emphasis will be placed on a variety of clinical research conducted on MUSC's campus. Only $2.99/month. The NIH does not endorse any specific training programs. © 2016 Microsoft musc.edu Privacy Help Certified courses titles below link to our course catalog. The NIH does not endorse any specific training programs. 3. H����?9�_�=��#��>d�ԍ��͕�a���ࠏN��iw��uP���c� Research and discovery programs at MUSC promote health, reduce the risk of illness and disease, and build community resilience. There is no uniform standard regarding how frequently GCP training should occur. S���.��廼?f�Ɇ��vW��? Version 2 refers to the ICH E6(R2) revisions to the TransCelerate BioPharma’s minimum criteria for mutual recognition. The GCP - Social and Behavioral Research Best Practices for Clinical Research course applies GCP principles to behavioral intervention and social science research studies. ���� V;�eb�\������Z. Why did you receive the requirement for Good Clinical Practice (GCP) training? For basic GCP courses, it is highly recommended that organizations present all modules in a given course as required for a learner to earn a completion report. A refresher course provides retraining. This is to comply with the NIH Policy, effective as of January 1, 2017. For login assistance, please call 843-792-9700. GCP refresher courses are meant to reinforce the importance of concepts covered in the basic level GCP course. The Belmont Report is required reading for all CITI Program participants as it provides the ethical framework for the federal regulations designed to protect human research subjects. All investigators involved in biomedical or socio/behavioral research must complete both a Good Clinical Practice (GCP) and a basic course. All investigators and key personnel who participate in the design, conduct, or reporting of human subjects research (including exempt research) must be appropriately trained in the protection of human subjects. For non-MUSC users wishing to take the training, the procedure requires the non-MUSC individual to be sponsored by a MUSC employee. The CITI Program recommends that learners complete the basic level GCP course first, and then take a refresher GCP course at the interval designated by their organization. GCP training is a separate training and is not basic human subjects protection training. Once you log into LMS search “NIH” to locate the course. CITI Program also offers some additional resources on ICH E6(R2). Some organizations will make several modules supplemental, particularly when they provide organization-specific training on the topic. Good Clinical Practice (GCP) Featured Provides essential GCP training for research teams involved in clinical trials of drugs, biologics, and devices, as well as those involved in behavioral intervention and social science studies. The following GCP ICH E6 Investigator Site Training courses also meet the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors and have been updated to include ICH E6(R2): Refresher Courses - English with ICH E6(R2). 136 0 obj <> endobj 159 0 obj <>/Filter/FlateDecode/ID[<22D8F9617AF71F8EAE246F517FD63E64><0CC7248BCBA14E34999DD2FF30B064DE>]/Index[136 50]/Info 135 0 R/Length 103/Prev 227183/Root 137 0 R/Size 186/Type/XRef/W[1 2 1]>>stream h�bbd``b`A@��H� &> �� We will work with your CITI Program designated admin to determine the learner groups that best fit your organizational needs. The IRB will not review or approve a submitted research proposal until all training requirements are met. These courses also include corresponding refresher courses for retraining and advanced learning. melanie9stew. Learn. Do's and Don'ts of Informed Consent(YouTube Instructional Video from Emory University 7m 57s) Click Commerce eIRB - eIRB Training & Guidance These articles identify courses that comply with the NIH GCP Policy and answer FAQs for NIH Policy on GCP training. vt U��� B@�����(�jR� �tI��`MK���hp PK�!�&Ac� Gravity. MCR*746. h��Xms�6�+�x��ջԹ�CBH2 �4�^Z&|�#�Ȁs/��������x�d��J��>Z� 0`�p�9#�kɄVX+&��Z3�6Ls��*zw8?xZ��-0�X΄0�Lg��B�Gm���!ͤP(�&�� Xˤ�pL��ɞ)�z��I�y����\�$ӂ�v����޽�;�7�y:��ǻ��?c�Kܹ����p6ʦcl^w���p���p8���(�Φ9���\��N:_��ShR�NF����р���pE���C��Op���>>�?��x6���U��p���M:��F� +#/4s*B�z&Yr�ȹW(V*��G�%D��ɹ��A�`��A|qrr�,�#�Ӝy-����l��#�l|�g�����Z�˸;I��d ����Ǡ�5g-E��b��.�v�I��S>�z����E�L�a{:����4 p.�%?�} !t��Ӈs� 4>�ƋC�l��7����骣����}2_�w�#:�2)��q�濝?�ac�����z��2�M��Gh�Ԣ����a�k�Zv�t�A�X!���Ff����H#�B����(�4�Jk����� ��(��Z-� �¾H� &�v���|,� Lr]�a�j��]h+���Ў�H9��ѻ"�ˀ3�p�W1�R�) �%A���Z8 ��������e��KҶ-��ưӮ;�v���z�����������+���P�MwSp�� +�j�(�r(�� ���7G�4�r �N��VQ6P���,������ The CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Devices Provides an introduction to the course and a link to the Belmont Report. Associate Professor Director, COM Senior Mentor Program Interim Director, Center for Aging Judson Chandler, Ph.D. GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) and GCP ICH Refresher are suitable for individuals involved in clinical trials of drugs and biologics when the research may be international or where the individuals would prefer a more ICH-focused curriculum. MCR 700-01 Clinical Biostatistics-An introduction to basic and intermediate statistical techniques used to analyze and interpret data in health sciences and related fields. Good Clinical Practice (GCP) training is required for all individuals involved in the conduct of clinical trials in any of the following categories: Biomedical clinical trials submitted for initial IRB approval on or after November 1, 2016, with any source of funding or support; and. Test. CITI Program: Good Clinical Practice (Updated: January 2017) citiprogram.org 2 Table of Contents Basic Courses Page GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) 3 GCP for Clinical Trials with Investigational 10Drugs and Biologics (ICH Focus) On January 1, 2018, to align with NIH practices, CITI training requirements were updated. GCP principles are specific to clinical trials and include international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials. CITI Program offers several GCP courses that are considered acceptable by many leading organizations to meet their training needs per NIH policy released on 16 September 2016. Upgrade to remove ads. h�b```�VN``a`b��@\&� ?�4�s=c�ȼ��(�?W'�v��s>���f���3%jf[�̜�g�n��� �k����P��cG�͌����D#��S�7�F E�X�&,:�Z!��Y�e�� @���m � 2�K�@xc��ɦF�ͼb2[�b'sk ���9t - z#�����]�$ُ� �m5�r���������g� �h�rF�²�E����;�m�y[�d��L2he�%Dm�X�B�D�q��l�F��*���-�F.x���-�+����ȥ59��rg4u��d�P*v@#;g� �\�+��~ |i#���N�W^�|��̯8�N�%����ON�;�L��j�3��غ����ɕ2��F�5���ZV�n�e8(�����|���@��)�!��6~���eM�ڞ�\t�,jy0�kY�/═n�`�Zq��\m�߉IKL��7T�������8���{4���q>ϓ�h6��t����_~L��E�7��/��� L�ڎ endstream endobj 140 0 obj <>stream As a rule of thumb, modules can take about 30 to 45 minutes to complete, which means it could take around three to six hours to complete a GCP course. For more information on how to ensure CME credit availability for learners at your organization, contact support@citiprogram.org or 888.529.5929. GCP is mandatory for Principal Investigators (PI)s and study staff working on FDA regulated studies or NIH funded studies that fit the NIH definition of a clinical trial. The University requires that NIH-funded investigators and staff complete Good Clinical Practice (GCP) Training every three (3) years through the Collaborative Institutional Training Initiative (CITI) Program. Yes, after the ICH Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) was adopted on 15 December 2016, the CITI Program modules were revised to reflect the current guideline. Topics include descriptive statistics, graphical methods and probability with applications to epidemiology, discrete and continuous distributions, inference on means, nonparametric methods, and inference on proportions, contingency t… %PDF-1.6 %���� �2�Jz��pf`�=�E�X��|,s'�:Md�"�Ԥ�^!�Է��GӼ큧;��3����|��˿�:*�N30�|(s8�d �{椛@��6n�SDs�D�Q � 5.�M endstream endobj 137 0 obj <> endobj 138 0 obj <>/Font<>/ProcSet[/PDF/Text/ImageC]/XObject<>>>/Rotate 0/Type/Page>> endobj 139 0 obj <>stream Professor Christopher W. Cowan, Ph.D. Accessible at www.citiprogram.org Created by. This course provides students with the basic structure of clinical research, mentorship, resources for professional research available throughout the campus. Yes, CITI Program will notify administrators via eBlast (email) and post announcements on our website when courses are significantly revised or updated. The Medical University of South Carolina Founded in 1824, the Medical University of South Carolina (MUSC) continues the tradition of excellence in education, research and patient care. We use cookies and other tracking technologies to recognize your repeat visits and preferences, as well as to analyze traffic and measure the effectiveness of communications. Researchers are responsible for complying with the International Council on Harmonisation (ICH) - Good Clinical Practice (GCP) Guidelines (E6) when required by the sponsor. Good Clinical Practice (GCP) Guidance (E6) National Institutes of Health. The CITI Good Clinical Practice (GCP) training module is now required of all UNC-CH investigators and research staff who are involved in the design, conduct, or reporting of clinical trials involving human subjects and a drug, device or biologic is … Learners may complete the modules at their own pace. Spell. Good Clinical Practice (GCP) includes basic courses tailored to the different types of clinical research. The NIH does not endorse any specific training programs. GCP consists of basic and refresher courses that provide essential good clinical practice training for research teams involved in clinical trials of drugs, biologics, and devices, as well as those involved in behavioral intervention and social science research studies. Create. Along with CITI Program's advantages, including our experience, customization options, cost effectiveness, and focus on organizational and learner needs, this makes it an excellent choice for GCP training. ��jfd�v��n ��h��*�B�P��%G70�@���t�奏�=�2�� #�갦�+ lmF��ÑY���..�Q��. Good Clinical Practice (GCP) includes basic courses tailored to the different types of clinical research. Learners should take the GCP course that best meets the type of research they conduct: GCP courses vary on the number of modules they contain. CITI Program GCP training is used by over 1,500 institutions - (including many leading hospitals, academic medical centers, universities, and healthcare companies) - to meet their GCP training needs. GCP - Social and Behavioral Research Best Practices for Clinical Research and GCP SBR Advanced Refresher are suitable for social and behavioral investigators and staff who must be trained in GCP. Developed & Maintained by the Success Center in Collaboration with the Office of Research Integrity. However, most organizations select a three-year period of retraining. 15 modules must be completed with a passing score of 80% 4. MUSC College of Medicine Policies COM Technical Standards for Admission, Retention, and Graduation Medical Scientist Training Program (MD/PhD) Transfer Policy Accreditation vs. Licensure to Practice Medicine. 1. For the GCP SBR Advanced Refresher, only five of the modules are required for mutual recognition of the course – see course page for more information.