Office of Research Administration Standard Operating Procedures for the Conduct of Clinical Research SOP Manual for Compliance with International Conference on Harmonization (ICH) Good Clinical Practice Guidelines and FDA Regulations at the Investigative Site Street Address 207 Schwartz Center, 800 E. Summit St., Kent, OH 44242-0001 Mailing Address 800 E. Summit St. Kent, OH 44242 Clinical Research Center Standard Operating Procedures. NIH and Other Federal Guidelines/Policies for Clinical Research. A set of standard operating procedures (SOPs) provides a clinical research de- partment with clear roles, responsibilities, and processes to ensure compliance, accuracy, and timeliness of data. Enter the email address you signed up with and we'll email you a reset link. . ��`S__�_x �C��CR�ť Research Project Management 81 20.0 General Guidelines of Study Management 81 20.1 Tracking Key Parameters 81 20.2 Study Management Meetings 82 21.0 Study Documentation Management 82 21.1 Regulatory Binder—General 82 21.2 Regulatory Binder—Additional Element for Drug and Device Studies 83 21.3 Manual of Operations 84 21.4 Financial Documents 84 22.0 Data … Research agreements with industry for clinical research involving investigational drugs or medical devices should incorporate administrative provisions (indemnification and subject injury reimbursement) to ensure that there are safeguards to protect the University from medical costs, claims, and suits from the adverse effects of the study. Campbell Clinic/Foundation Clinical Research Standard Operating Procedures Page 4 However, the IRB application may need to be amended, suspended or withdrawn pending CFCM action(s). Mandatory policies and guidance for studies involving human subjects. Sorry, preview is currently unavailable. Clinical Trial Units are expected to maintain a hard copy of the current IMPAACT MOP at all clinical research sites. (ICH GCP 1.55) Manual of Operations: A handbook of instructions designed to guide the research team to successfully carry out aspects of a research study according to study protocol. The following guidelines and templates ensure consistent operating procedures and oversight for clinical research studies. It operationalizes the study protocol and describes each step of the study and how it is to be executed. establish written procedures for moni- specific procedures for compliance. �U~ � _rels/.rels �(� ���J�@���̽����4�E��D���$����T۷w-�j҃ǝ���|�zs��z�z�*X%(vڛ޵�6O�{PI��� Manual of Procedures. The SOPs within this manual describe standardized processes and provide instruction for various procedures related to the conduct of clinical research at University Hopsitals and are meant to promote consistency for those involved. DGHI is pleased to share these documents with others who are working in resource-limited locations. Maintaining a record for all Research Personnel of all training certifications, including all certificates of completion of applicable training modules and, if necessary, any sponsor required documents (e.g., CVs) in the Regulatory Binder. You can download the paper by clicking the button above. Below is the definition of “clinical trial.” Clinical trial means a research study in which one or more Investigators are responsible for ensuring that the protocol documents adhere to all applicable in-country, local, and institutional laws, regulations, guidelines, and policies. e6]օ����+�x.���J������DČ��������(�y�s�i��r>������c ��2V���U�dZ��!�HF�\QR�$BX�R���� ��7A�t��l��"������} o~�w��J$�%�@"I�v����T}g:�OJ����L���7� �A�8��H�!k4��뎳����#�z��y�6 �S�3�t��^*1�`q���آz�� �)�B��� ��fCo6r3 ~{q�gC��5��z3���&+ � �SИaT}�}1 ��D��>¨�SSL���(-������E�1M���&�m��;ō ���`d��(� \/�:?I��dB1� �nr��Y�3�޷��ch�-��b�`�Yo����u�+E�;B����m���n�s1!T)7-Eգ9��D�f���+�C���ohϡ����CS�C�d� `b`��|,�7����V�?�.��/_�ï��7��� ���u�Ō(�+��(��%�l�[5e�9�Zc�D[p8T��U5�oA “Detailed, written instructions to achieve uniformity of the performance of a specific function.” (ICH GCP 1.55) In simple terms an SOP is a written process and a way for the clinical site to perform a task the same way each time it is completed. A Manual of Procedures (MOP) is a handbook that details a study’s conduct and operations as well as facilitates consistency in protocol implementation and data collection across study participants and sites. MANUAL OF PROCEDURES Revised June 2008 Sudden Hearing Loss Multicenter Treatment Trial Study Chair and Steering Committee Chair Steven D. Rauch, MD, Massachusetts Eye and Ear Infirmary, Boston, MA Senior Study Audiologist Christopher F. Halpin, PhD, Massachusetts Eye and Ear Infirmary, Boston, MA Senior Clinical Research Coordinator :��#@ � word/_rels/document.xml.rels �(� �Y˒�6ݧ*�@y���I�{L'�b�Mj���,�JےK����b� t� CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures.