Clinical Procedures Clause Samples
The Clinical Procedures clause defines the standards and protocols that must be followed when conducting medical or clinical activities under the agreement. It typically outlines the responsibilities of the parties regarding the performance, documentation, and oversight of clinical interventions, such as patient care, data collection, or investigational treatments. By establishing clear expectations for how clinical procedures are to be carried out, this clause ensures compliance with regulatory requirements and promotes patient safety, thereby reducing the risk of errors or misunderstandings during the course of clinical work.
Clinical Procedures. The Company is conducting (or is causing to be conducted), and has conducted (or caused to be conducted) all aspects of its research and development activities related to the products that it is developing (the “Products”), including, without limitation, the preclinical and clinical tests and studies of such Products, in compliance in all material respects with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and applicable local, state and federal laws, rules, regulations and guidances, including, but not limited to, the principles of Good Clinical Practice, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, and has made all reports, filings and notifications required thereunder, including, but not limited to, the reports required by 21 C.F.R. § 312.32. To the Company’s knowledge after reasonable investigation, research involving human subjects conducted by or for the Company has (i) been conducted in compliance in all material respects with all applicable federal, state, and foreign statutes and regulations governing the protection of human subjects and (ii) not involved any investigator who has been disqualified as a clinical investigator by the FDA or any other agency. To the Company’s knowledge after reasonable investigation, the Company has conducted its clinical investigations in accordance in all material respects with Institutional Review Board approvals and requirements, if applicable, and, to its knowledge has obtained informed patient consent where required by the applicable requirements of 21 C.F.R. Part 50 and any other requirements of the applicable jurisdiction, except where the failure to obtain such consent would not materially and adversely affect the Company. To the Company’s knowledge, the Company is not the subject of any investigation by the FDA or any other agency. Neither the FDA nor any other regulatory authority has issued any clinical hold orders, warning letters, notices of violation, or similar correspondence or communications with respect to such tests, studies or Products.
Clinical Procedures. The supervisee agrees to meet with clients and perform psychotherapeutic or other clinical functions in a professional, reliable, and responsible manner. The supervisee agrees to implement to the best of his or her ability the recommendations made by the supervisor for the handling of each case. The supervisee agrees to develop adequate, appropriate, and current written treatment plans.
1. Sensitivity, responsiveness, and flexibility. The supervisor agrees to try always to bear in mind issues of diversity, particularly their many dimensions and influences, and to be sensitive and respectful of all differences among the client(s), the supervisee, and himself or herself. The supervisor agrees to attend to the boundaries, balances, and potential multiple relationships between the supervisor and supervisee. In all cases, the interests of the supervisee will be held primary. The supervisor agrees to maintain awareness of the sometimes fine line between doing supervision and providing psychotherapy. If the supervisor should decide that the supervisee can benefit from psychotherapy, he or she will make referrals.
Clinical Procedures. QuatRx is conducting (or is causing to be conducted), and has conducted (or caused to be conducted) the preclinical and clinical tests and studies of the products which QuatRx is developing (the "QUATRX PRODUCTS") in compliance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and applicable local, state and federal laws, rules, regulations and guidances, including, but not limited to, the principles of Good Clinical Practice, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, and has made all reports, filings and notifications required thereunder, including, but not limited to, the reports required by 21 C.F.R. Section 312.32. QuatRx has provided documents describing the clinical studies and tests, including related results and regulatory status, and they are complete and accurate in all material respects, and QuatRx, after diligent search, is not aware of and clinical studies or tests the results of which reasonably call into question the clinical study and test results provided by QuatRx. Except as set forth in Section 6.20 of the QuatRx Disclosure Schedule, neither the FDA nor other regulatory authority has issued any clinical hold orders, warning letters notices of violation, or similar correspondence or communications with respect to such tests, studies or QuatRx Products.
Clinical Procedures. Hormos is conducting (or is causing to be conducted), and has conducted (or caused to be conducted) the preclinical and clinical tests and studies of the products which Hormos is researching and/or developing (the "HORMOS PRODUCTS") in compliance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and applicable Law. Hormos has provided documents describing the clinical studies and tests, including related results and regulatory status, and they are complete and accurate in all material respects, and Hormos, after diligent search, is not aware of and clinical studies or tests the results of which reasonably call into question the clinical study and test results provided by Hormos. Neither the FDA nor other regulatory authority has issued any clinical hold orders, warning letters notices of violation, or similar correspondence or communications with respect to such tests, studies or Hormos Products, except as set forth in Section 4.28 of the Hormos Disclosure Schedule.
Clinical Procedures. THE COMPANY IS CONDUCTING (OR IS CAUSING TO BE CONDUCTED), AND HAS CONDUCTED (OR CAUSED TO BE CONDUCTED) THE PRECLINICAL AND CLINICAL TESTS AND STUDIES OF THE PRODUCTS WHICH THE COMPANY IS DEVELOPING (THE "Products") IN COMPLIANCE WITH EXPERIMENTAL PROTOCOLS, PROCEDURES AND CONTROLS PURSUANT TO ACCEPTED PROFESSIONAL SCIENTIFIC STANDARDS AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS, RULES, REGULATIONS AND GUIDANCES, INCLUDING, BUT NOT LIMITED TO, THE PRINCIPLES OF GOOD CLINICAL PRACTICE, THE FEDERAL FOOD, DRUG AND COSMETIC ACT AND IMPLEMENTING REGULATIONS AT 21 C.F.R. PARTS 50, 54, 56, 58 AND 312, AND HAS MADE ALL REPORTS, FILINGS AND NOTIFICATIONS REQUIRED THEREUNDER, INCLUDING, BUT NOT LIMITED TO, THE REPORTS REQUIRED BY 21 C.F.R. Section 312.32.. THE COMPANY HAS PROVIDED DOCUMENTS DESCRIBING THE CLINICAL STUDIES AND TESTS, INCLUDING RELATED RESULTS AND REGULATORY STATUS, AND THEY ARE COMPLETE AND ACCURATE IN ALL MATERIAL RESPECTS, AND THE COMPANY, AFTER DILIGENT SEARCH, IS NOT AWARE OF AND CLINICAL STUDIES OR TESTS THE RESULTS OF WHICH REASONABLY CALL INTO QUESTION THE CLINICAL STUDY AND TEST RESULTS PROVIDED BY THE COMPANY. NEITHER THE FDA NOR OTHER REGULATORY AUTHORITY HAS ISSUED ANY CLINICAL HOLD ORDERS, WARNING LETTERS NOTICES OF VIOLATION, OR SIMILAR CORRESPONDENCE OR COMMUNICATIONS WITH RESPECT TO SUCH TESTS, STUDIES OR PRODUCTS..
Clinical Procedures. To ensure that all clinical information related to the service is recorded in the patient’s own GP held lifelong record, including the completion of the “significant event” record that the patient is on anticoagulation.
Clinical Procedures. The supervisee agrees to meet with clients and perform psychotherapeutic or other clinical functions in a professional, reliable, and responsible manner. The supervisee agrees to implement to the best of his or her ability the recommendations made by the supervisor for the handling of each case. The supervisee agrees to develop adequate, appropriate, and current written treatment plans and will remain responsible for such. These will be reviewed at scheduled times with the client(s) and supervisor, and changes will be incorporated as needed.
1. Sensitivity, responsiveness, and flexibility. The supervisor agrees to try always to bear in mind issues of diversity, hierarchy, and privilege in their many dimensions and influences, and to be sensitive and respectful of all differences among the client(s), the supervisee, and him- or herself. The supervisor agrees to attend to the boundaries, balances, and potential multiple relationships between the supervisor and supervisee. In all cases, the interests of the supervisee will be held primary. The supervisor agrees to maintain awareness of the sometimes fine line between doing supervision and providing psychotherapy. If the supervisor should decide that the supervisee can benefit from psychotherapy, he or she will make referrals. The supervisor agrees to continue to learn about supervision. The supervisor agrees to remain current in the model(s) and methods of assessment, therapy, legal and ethical issues, and similar clinical concerns.