Investigator-Initiated Research Terms and Conditions
All submitted proposals and related documents, including study concepts and protocols, shall be deemed Non-Confidential. No confidential relationship shall be established or implied by SpringWorks' acceptance of such materials.
SpringWorks shall have the right to retain any such materials. SpringWorks will only consider unsolicited IIR proposals submitted in writing by external investigators interested in studying SpringWorks drug candidates in therapeutic areas of interest. Support from SpringWorks, if any, will be granted on the basis of scientific merit. IIR budgets must be reasonable and appropriate for the proposed study.
Acceptance of the submission of a study concept or protocol does not constitute approval. SpringWorks reserves the right to decline support of a proposal any time after submission.
Following review by SpringWorks, the submitter will be notified as to whether the IIR proposal has been approved or denied, or if additional information is required. Approval of a study concept does not guarantee approval of a study protocol. SpringWorks shall have no obligation to give the reasons for its decisions.
SpringWorks support of an IIR will be subject to the execution of a written agreement which shall include terms aligned with the following principles:
- Conduct of the Study. The IIR will be conducted in accordance with the final protocol as approved by SpringWorks, International Conference on Harmonization Good Clinical Practice (ICH GCP) guidelines, and all applicable governmental laws, rules, and regulations. Also, if study drug is supplied by SpringWorks as part of an IIR, the Institution is expected to follow SpringWorks instructions such as those regarding proper handling of study drug (e.g., storage and handling, expiration of drug notices, drug disposal or destruction).
- Sponsorship. The Institution, not SpringWorks, will be the sponsor of the IIR. The Institution, the Principal Investigator and the Institution staff will not represent to any third party, including IIR subjects, that SpringWorks is a sponsor.
- Regulatory. The Institution will be solely responsible for any and all safety reporting and regulatory obligations associated with the conduct of the IIR, including, but not limited to, obtaining and maintaining an Investigational New Drug application (IND), if required.
- IRB/IACUC Approval. The Principal Investigator will ensure that the IIR is approved by and subject to continuing oversight by an appropriate Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC), and shall provide to SpringWorks a copy of such approval, and any extensions or renewals.
- Informed Consent. For clinical studies, the Principal Investigator will obtain informed consent for each IIR subject in accordance with 21 Code of Federal Regulations Part 50 (unless an exemption under such part has been approved by the IRB and documentation of same can be provided), and will inform IIR subjects that SpringWorks is providing support for the IIR. SpringWorks shall have the right to review and comment on the informed consent form.
- Registration of Study. For clinical studies, the Principal Investigator shall register the IIR at either (i)https://www.clinicaltrials.gov, or (ii) any other registry the requirements of which are consistent with the guidelines of the International Committee of Medical Journal Editors ("ICMJE") on trial registrations, in each case to the extent required by the ICMJE guidelines (as in effect at the time the IIR begins) in order for the IIR results to be eligible for publication in an ICMJE journal.
- Reporting of Serious Adverse Events. For clinical studies utilizing a SpringWorks study drug product, within 24 hours of first awareness of the event (immediately if the event is fatal or life-threatening), the Principal Investigator will report to SpringWorks by email any Serious Adverse Event ("SAE") that occurs during the SAE reporting period (as defined in the agreement) in an IIR subject assigned to receive the SpringWorks study drug. The Principal Investigator will report to the appropriate Regulatory Authority (e.g., FDA) such SAEs using an FDA MEDWATCH form, and shall do so within the time frames set forth by FDA regulations. SAEs should be reported as soon as they are determined to meet the definition, even if complete information is not yet available.
- Disclosure. SpringWorks will publicly disclose at its discretion, and in accordance with the information maintained in its internal business records, the name of the Institution and/or the Principal Investigator and certain information relating to the agreement including, but not limited to, any financial and in-kind payments received under the agreement, the nature of the engagement and any other payment or service-related information as may be deemed appropriate by SpringWorks or as may be dictated by applicable law. Payments to the Institution for work done by specified individuals may reference both the Institution and the individual.
