Study Conduct Clause Samples
The Study Conduct clause defines the standards and procedures that must be followed during the execution of a research study or clinical trial. It typically outlines the responsibilities of the parties involved, adherence to protocols, compliance with regulatory requirements, and the maintenance of accurate records. For example, it may require that all study activities are performed according to approved protocols and that any deviations are documented and reported. The core function of this clause is to ensure the integrity, reliability, and regulatory compliance of the study, thereby protecting both the validity of the results and the interests of participants.
Study Conduct. 2.1 MD ▇▇▇▇▇▇▇▇ and Sponsor will each use its own facilities and its reasonable best efforts to conduct its respective obligations in the performance of the Study, in accordance with Exhibit A and applicable laws and regulations. For MD ▇▇▇▇▇▇▇▇, the Study shall be performed under the direction of ▇▇▇ ▇▇▇▇▇, M.D., Ph.D., or his/her successor as mutually agreed to by the Parties (the “Principal Investigator”). In the event of any conflict between Exhibit A and this Agreement, this Agreement shall control. MD ▇▇▇▇▇▇▇▇ shall provide all necessary personnel, equipment, supplies, facilities and resources to perform MD Anderson’s obligations in the Study, and shall be fully responsible for the activities of any MD ▇▇▇▇▇▇▇▇ personnel to whom Study activities are delegated. Sponsor shall provide all necessary personnel, equipment, supplies, facilities and resources to perform Sponsor’s obligations in the Study, and shall be fully responsible for the activities of any Sponsor’s personnel to whom Study activities are delegated.
2.2 Sponsor understands and acknowledges that MD Anderson’s primary mission is the development and dissemination of scientific knowledge, and that MD ▇▇▇▇▇▇▇▇ makes no representations, certifications, or guarantees with respect to any specific results of the Study. MD ▇▇▇▇▇▇▇▇ understands and acknowledges that Sponsor makes no representations, warranties, or guarantees with respect to any specific results of the Study.
2.3 Sponsor understands and acknowledges that MD ▇▇▇▇▇▇▇▇ may be involved in similar research through other researchers on behalf of itself and others. Except as expressly stated in this Agreement, nothing in this Agreement will limit or prohibit MD ▇▇▇▇▇▇▇▇ or any of its personnel, including the Principal Investigator, from conducting any research or for performing research for or with any entity or person, including any other outside sponsors. Sponsor acknowledges that this provision is intended to preserve the academic freedom and integrity of MD ▇▇▇▇▇▇▇▇ and its faculty and to ensure that MD ▇▇▇▇▇▇▇▇ and its faculty are not regarded as captive researchers for Sponsor.
Study Conduct. CRO shall conduct the Services of each IPA in accordance with the applicable provisions each Study protocol, agreed SOPs, the current Guidelines for Good Clinical Practices for Trials (“GCP Guidelines”), and all applicable local, state, and federal laws and regulations governing the performance of clinical investigations including, but not limited to, the Federal Food, Drug and Cosmetic Act and regulations of the Food and Drug Administration (“FDA”) and the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and regulations of the Department of Health and Human Services (“HHS”).
Study Conduct. 3.1 Antigen Express’s willingness to provide the Study funding and supply the Antigen Express Study Drug pursuant to this Agreement is predicated upon (a) its review of, and the mutual agreement of the Parties with respect to, the Protocol; (b) Subject enrollment and Study progress in accordance with Appendix B, and (c) the terms and conditions of this Agreement.
3.2 The Study will be performed in accordance with the terms and conditions contained herein, the terms and conditions of the Protocol, and all applicable laws, rules, regulations, and guidelines including but not limited to those regulations promulgated by the FDA including ▇▇ ▇▇▇ ▇▇▇, as applicable, federal and state privacy and patient confidentiality laws, and ICH Good Clinical Practices (collectively, “Applicable Law”).
3.3 Antigen Express acknowledges that NSABP does not consider itself a HIPAA-covered entity; however, NSABP shall collect, use, store, access, and disclose personal health information (as that term is defined in HIPAA) (“PHI”) collected from Subjects only as permitted by the IRB approved Informed Consent Form or HIPAA authorization form obtained from a Subject. Antigen Express agrees that, to the extent Antigen Express and any Antigen Express designee has access to PHI, Antigen Express and such Antigen Express designee shall collect, use, store, access, and disclose PHI collected from Subjects only as permitted by the IRB approved Informed Consent Form or HIPAA authorization form obtained from a Subject. Any IRB approved Informed Consent Form or any HIPAA authorization form shall expressly permit Antigen Express to share Data with Merck. In order for Antigen Express to share or provide any Data that includes PHI with Merck, Antigen Express shall first obligate Merck to store, use, process, and handle any such Data with PHI only as permitted by the IRB approved Informed Consent Form or HIPAA authorization form.
3.4 NSABP or Antigen Express may at any time suggest amendments to the Protocol as may appear desirable; such amendments shall be discussed between Antigen Express and NSABP and (except as set forth below) such amendments may be made binding only upon mutual, signed written amendment to the Protocol. If such amendments are requested by Antigen Express and have been agreed to by NSABP, and such amendments increase or decrease the costs of the Study, NSABP will submit to Antigen Express a written estimate of the difference in costs arising from the amendments requested by ...
Study Conduct. (a) Institution agrees to conduct any Study in strict compliance with:
(i) the Study Protocol, as approved by Introgen, Investigator, Institution and its responsible Institutional Review Board (along with any subsequently approved (by all parties) written amendments to the Study Protocol);
(ii) all applicable local, state and federal laws, rules and regulations;
(iii) all applicable medical privacy laws or regulations; and
(iv) the terms of this Master Agreement and the applicable Study Specific Agreement.
(b) Institution and Investigator will use any Materials only to conduct the Study in accordance with the Protocol; will not chemically, physically or otherwise modify Materials, unless specifically required to do so by the Protocol; and will handle, store, and ship or dispose of Materials in compliance with all applicable local, state and federal laws, rules and regulations including, but not limited to, those governing hazardous substances. Institution and Investigator will not charge any Study subject or third-party payor for any Materials, or for Study procedures for which payment by Introgen has or will be made under the applicable Study Specific Agreement.
(c) In accordance with mutually agreed time periods, Institution will resolve all written data queries from Introgen and will deliver to Introgen any Study-related deliverables identified in writing by Introgen and agreed to by Investigator/Institution.
(d) Institution represents and certifies that no individual or entity will provide services on behalf of Institution in connection with a Study if that individual or entity has been debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. § 335a(a) and (b) (or regulations promulgated thereunder); disqualified as a testing facility under the provisions of 21 C.F.R. Part 58, Subpart K; or disqualified as a clinical investigator under the provisions of 21 C.F.R. § 312.70. Institution will notify Introgen of any action with respect to debarment or disqualification against Institution or any individual or entity providing services on behalf of Institution in connection with a Study.
(e) Institution represents and certifies that it practices good animal care and use practices and is accredited by the American Association for Accreditation of Laboratory Animal Care (AAALAC). Any animals that receive any of the Materials in the course of investigations or products derived from such animals will not be used for food purposes at a...
Study Conduct. The investigator agrees to perform all aspects of this study in accordance with the ethical principles that have their origin in the Declaration of Helsinki, ICH E6(R2): Good Clinical Practice; the protocol; and all national, state, and local laws or regulations.
Study Conduct. Licensee shall conduct Clinical Trials in compliance with Applicable Law and regulatory standards, including, as applicable, those relating to Good Laboratory Practices (“GLP”), Good Clinical Practices (“GCP”), pharmacovigilance and safety reporting, and requirements for the protection of human subjects.
Study Conduct. 1. The Sponsor with the Institution has designated the Principal Investigator to recruit patients into, and participate in the Study as a Study site. The Institution assures that the Principal Investigator has sufficient authority, competence, and experience in clinical trials, as well as medical and scientific skills to participate in this Study, according to any legal and health applicable requirements. The Institution and the Principal Investigator will use their best efforts to recruit approximately . patients. The parties agree that the increase of the number of patients to be enrolled at the Institution will require written approval from the Sponsor, but not an amendment to this Agreement. Patient enrolment will stop when the total number of patients as specified in the Protocol has been recruited between participating sites.
Study Conduct. Principal Investigator will conduct the Study in accordance with the Protocol, Sponsor written instructions, International Conference on Harmonization Good Clinical Practice (ICH GCP) guidelines, and all applicable governmental laws, rules, and regulations.
Study Conduct. (All studies) a) Ensure that the Study is managed according to GCP (as defined in the Protocol), all relevant legislation, and the Protocol ✓ [Sponsor’s Protocol Reference Number], [Name of Site Principa1l Investigator] NHS-ABPI-BIA model Clinical Trial Agreement 2011 -– England – (DRAFT revision 2015 v0.4) RESPONSIBILITY to: Sponsor Trust If ACTIVITY is delegated, name the body / individual delegated to: b) Ensure that the Study is conducted locally according to GCP, all relevant legislation, and the Protocol ✓
Study Conduct. (All studies) a) Ensure that legislation in relation to research is followed within the Site NHS Organisation b) Ensure that the Study Site team members are appropriately qualified and experienced to undertake the conduct of the Study and that they have current substantive or honorary employment contracts in place, where required. NHS Organisation c) Ensure that no Participant is recruited until a favourable ethical opinion has been provided Sponsor and NHS Organisation d) Ensure that no Participant is recruited to the Study until satisfied that all relevant regulatory permissions and approvals have been obtained. Sponsor and NHS Organisation e) Put and keep in place arrangements to allow all investigators to conduct the Study in accordance with the Protocol and clause 2 of this Agreement Sponsor and NHS Organisation f) Ensure that the Study is managed, monitored and reported as agreed in the Protocol. Sponsor and NHS Organisation g) Ensure that the rights of individual Participants are protected and that they receive appropriate medical care whilst participating in the Study. NHS Organisation Responsibility to: Responsible Party: If Responsibility is delegated, name the body / individual thatit is delegated to: h) Maintain and archive Study documentation at the Site. NHS Organisation
i) Ensure that all data and documentation are available for the purposes of monitoring, inspection or audit and that the appropriate consent has been provided by the Participant. NHS Organisation
j) Inform appropriate health or social care professionals if their patient is a Participant in the Study in accordance with the Research Governance Framework. NHS Organisation
k) Ensure adequate facilities, resources and support are available to conduct the Study at the Site. NHS Organisation
l) Report suspected research misconduct. Sponsor and NHS Organisation
m) Notify the regulatory authority(ies) of the end of the Study. Sponsor
n) Notify the regulatory authority(ies) and relevant ethics committee if the Study is terminated early. Sponsor