Informed Consent Process Sample Clauses

Informed Consent Process. Potential participants will be presented with the Baseline Sleep Apnea Study #2 eICF on the Baseline Sleep Apnea Study #2 Web Portal.. Participants must be informed that their participation is voluntary. Participants will be required to sign a statement of informed consent that meets the requirements of 21 CFR 50, local Document Number regulations, ICH guidelines, Health Insurance Portability and Accountability Act (HIPAA) requirements, where applicable, and the IRB. If the potential participant agrees to the terms described in the Baseline Sleep Apnea Study #2 eICF and provides consent, study eligibility will be further assessed.
Sample 1
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Informed Consent Process. Obtaining informed consent is a process rather than an event and discussions to ensure participant understanding and continued willingness to participate should take place at every study visit. No trial activities will take place before the informed consent form has been signed by a participant or before the respective ethical review boards have given permission for the study. A research nurse will discuss the purpose, duration, procedures, alternatives, risks and benefits of the study with potentially eligible participants. The potential participant will be given the opportunity to ask questions or discuss the study with family members before signing the consent form. The nurse conducting the discussion will also ask the participant questions to assess the participant’s understanding. People who are not able to give informed consent for themselves, will not be included in this study. At Stellenbosch University the informed consent discussion will be conducted in English or Afrikaans, according to the preference of the participant. In the case of Xhosa speaking participants, an interpreter could be used to translate English or Afrikaans to Xhosa. Informed consent forms will be available in English, Afrikaans and Xhosa. The language used will be documented in the participant file. In the case of a participant who cannot read and write, an independent witness will be present during the discussion and will sign in addition to the participant’s thumbprint. This will also be documented in the participant file. The participant may withdraw consent at any stage and will be informed that withdrawal will not influence their routine clinical care. A participant may also be withdrawn from the study at the discretion of the study investigators if their further participation is somehow deemed to be a risk to their safety or if lack of the participant’s cooperation compromises the quality of the study.
Sample 1
Informed Consent Process. The informed consent process was managed by the interviewers. Before starting the interviews, a summary of the study and the role of the participant was read out by the interviewer. The objectives and nature of the study, as well as potential risks and benefits, were clearly explained to the participant. Each participant was assured of confidentiality; names were not to be recorded on the questionnaire, only phone numbers. It was also emphasized that participation in the study was completely voluntary, and that there was no penalty for refusing to participate. It was also explained to participants that they could still participate in the program intervention even when they decided to not participate in the study. The participants were given opportunities to ask questions before they appended their signatures on the informed consent. The consent forms were separated from the actual questionnaires and stored in a locked drawer. The information from the informed consent forms were not recorded anywhere, or entered into the study database.
Sample 1
Informed Consent Process. Study participation is voluntary. Potential subjects, and/or their legal representatives, are given the most current IRB-approved consent form) to read. They will be provided ample time for review and an opportunity to ask questions about the study. If they agree to participate, they will sign the consent form and be given a copy of the signed document for their records. The original signed copy of the consent form will be retained by the Principal Investigator. Each of these actions/steps will be documented. Only after Informed Consent has been obtained, may the study procedures begin.
Sample 1
Informed Consent Process. Prior to enrolling in the study, and before performance of any procedures, potential subjects will attend a screening session at which time they will be provided with full information concerning details of the study assessments and procedures. The investigator or his/her representative will explain the nature of the study to the subject or his/her legally authorized representative and answer all questions regarding the study. Subjects must be informed that their participation is voluntary. Subjects or their legally authorized representative will be required to sign a statement of informed consent that meets the requirements of 21 CFR 50, ICH guidelines, local regulations, and data privacy laws (eg, The General Data Protection Regulation (EU) 2016/679 [GDPR] and Health Insurance Portability and Accountability Act [HIPAA]) requirements, where applicable, and the IRB/IEC or study center. The medical record must include a statement that written informed consent was obtained before the subject entered the study and the date the written consent was obtained. The authorized person obtaining the informed consent must also sign the ICF. Subjects must be re-consented to the most current version of the ICF(s) during their participation in the study. A copy of the ICF(s) must be provided to the subject or the subject’s legally authorized representative.
Sample 1
Informed Consent Process. ‌ The Informed Consent Form (ICF) and the process to obtain the informed consent will comply with all local laws, regulations, and guidance. Karyopharm will provide to Investigators, in a separate document, proposed ICFs that are considered appropriate for this study and comply with the ICH GCP guidelines and regulatory requirements. Any changes to the ICFs suggested by the Investigator must be agreed to by Xxxxxxxxxx before submission to the IRB/IEC, and a copy of the approved version(s) must be provided to the Karyopharm after IRB/IEC approval. All patients, proxies or legal guardians must provide signed written or verbal informed consent as follows: • In a COVID-19 clinical trial, informed consent may be verbal in the presence of another hospital employee and/or a patient representative. In this case informed consent will be documented in the patient’s chart and informed consent will be obtained per usual practice when the patient or patient’s representative is able to provide after contamination concerns are no longer an issue. • In a COVID-19 clinical trial, if a patient is in an emergency situation informed consent will be obtained consistent with 21 CFR 50.24. Females of childbearing potential should be informed that taking the study drug may involve unknown risks to the fetus if pregnancy were to occur during the study and agree that in order to participate in the study they must adhere to the contraception requirement for the duration of the study and for 3 months after the last dose. If there is any question that the patient will not reliably comply, they should not be entered in the study. • The investigator or his/her representative will explain the nature of the study to the patient or his/her legally authorized representative or proxy and answer all questions regarding the study. • Patients must be informed that their participation is voluntary. Patients or their legally authorized representative will be required to sign a statement of informed consent that meets the requirements of 21 CFR 50, local regulations, ICH guidelines, Health Insurance Portability and Accountability Act (HIPAA) requirements, where applicable, and the IRB/IEC or study center. • The medical record must include a statement that written informed consent was obtained before the patient was enrolled in the study and the date the written consent was obtained. The authorized person obtaining the informed consent must also sign the ICF. • Patients must be re-consented to the ...
Sample 1

Related to Informed Consent Process

  • Informed Consent Both of us have reviewed this Agreement with independent legal counsel. We understand the content, legal effect, and consequences of this Agreement, and we are entering into this Agreement voluntarily, free from duress, fraud, undue influence, or coercion of any kind.

  • Notification Regarding Letting/Transfer If the Allottee lets out or transfers the said Apartment, the Allottee shall immediately notify the Promoter/Association (upon formation) of the tenant’s/transferee's address and telephone number.

  • Notice of a License Action Grantee shall notify their contract manager of any action impacting its license to provide services under this Contract within five days of becoming aware of the action and include the following:

  • Updated Information Submission by Interconnection Customer The updated information submission by the Interconnection Customer, including manufacturer information, shall occur no later than one hundred eighty (180) Calendar Days prior to the Trial Operation. The Interconnection Customer shall submit a completed copy of the Electric Generating Unit data requirements contained in Appendix 1 to the LGIP. It shall also include any additional information provided to the Participating TO and the CAISO for the Interconnection Studies. Information in this submission shall be the most current Electric Generating Unit design or expected performance data. Information submitted for stability models shall be compatible with the Participating TO and CAISO standard models. If there is no compatible model, the Interconnection Customer will work with a consultant mutually agreed to by the Parties to develop and supply a standard model and associated information. If the Interconnection Customer's data is materially different from what was originally provided to the Participating TO and the CAISO for the Interconnection Studies, then the Participating TO and the CAISO will conduct appropriate studies pursuant to the LGIP to determine the impact on the Participating TO’s Transmission System and affected portions of the CAISO Controlled Grid based on the actual data submitted pursuant to this Article 24.3. The Interconnection Customer shall not begin Trial Operation until such studies are completed and all other requirements of this LGIA are satisfied.

  • Governmental Consent No governmental orders, permissions, consents, approvals or authorizations are required to be obtained by the Company that have not been obtained, and no registrations or declarations are required to be filed by the Company that have not been filed in connection with, or, in contemplation of, the execution and delivery of, and performance under, the Transaction Documents, except for applicable requirements, if any, of the Securities Act, the Exchange Act or state securities laws or “blue sky” laws of the various states and any applicable federal or state banking laws and regulations.

  • Amendment Process Requests to amend the Demonstration must be submitted to CMS for approval no later than 120 days prior to the planned date of implementation of the change and may not be implemented until approved. Amendment requests must include, but are not limited to, the following:

  • Reporting Unauthorized Transactions You should notify us immediately if you believe your Access Codes or any Access Devices have been lost or stolen, that someone has gained access to the Security Procedure, or that someone has transferred or may transfer money from your Account without your permission or if you suspect any fraudulent activity on your Account. To notify us, call us at the number provided in Section 9.6 between 8:00 a.m. to 4:30 p.m. Central Time during a Business Day.

  • Approval Process Tenant shall notify Landlord whether it approves of the submitted working drawings within three business days after Landlord’s submission thereof. If Tenant disapproves of such working drawings, then Tenant shall notify Landlord thereof specifying in reasonable detail the reasons for such disapproval, in which case Landlord shall, within five business days after such notice, revise such working drawings in accordance with Tenant’s objections and submit the revised working drawings to Tenant for its review and approval. Tenant shall notify Landlord in writing whether it approves of the resubmitted working drawings within one business day after its receipt thereof. This process shall be repeated until the working drawings have been finally approved by Landlord and Tenant. If Tenant fails to notify Landlord that it disapproves of the initial working drawings within three business days (or, in the case of resubmitted working drawings, within one business day) after the submission thereof, then Tenant shall be deemed to have approved the working drawings in question. Any delay caused by Tenant’s unreasonable withholding of its consent or delay in giving its written approval as to such working drawings shall constitute a Tenant Delay Day (defined below). If the working drawings are not fully approved (or deemed approved) by both Landlord and Tenant by the 15th business day after the delivery of the initial draft thereof to Tenant, then each day after such time period that such working drawings are not fully approved (or deemed approved) by both Landlord and Tenant shall constitute a Tenant Delay Day.

  • Information Submission by Connecting Transmission Owner The initial information submission by Connecting Transmission Owner shall occur no later than one hundred eighty (180) Calendar Days prior to Trial Operation and shall include New York State Transmission System information necessary to allow the Developer to select equipment and meet any system protection and stability requirements, unless otherwise mutually agreed to by the Developer and Connecting Transmission Owner. On a monthly basis Connecting Transmission Owner shall provide Developer and NYISO a status report on the construction and installation of Connecting Transmission Owner’s Attachment Facilities and System Upgrade Facilities and System Deliverability Upgrades, including, but not limited to, the following information: (1) progress to date; (2) a description of the activities since the last report; (3) a description of the action items for the next period; and (4) the delivery status of equipment ordered.

  • Transmission Delivery Service Implications Network Resource Interconnection Service allows Interconnection Customer's Large Generating Facility to be designated by any Network Customer under the Tariff on Transmission Provider's Transmission System as a Network Resource, up to the Large Generating Facility's full output, on the same basis as existing Network Resources interconnected to Transmission Provider's Transmission System, and to be studied as a Network Resource on the assumption that such a designation will occur. Although Network Resource Interconnection Service does not convey a reservation of transmission service, any Network Customer under the Tariff can utilize its network service under the Tariff to obtain delivery of energy from the interconnected Interconnection Customer's Large Generating Facility in the same manner as it accesses Network Resources. A Large Generating Facility receiving Network Resource Interconnection Service may also be used to provide Ancillary Services after technical studies and/or periodic analyses are performed with respect to the Large Generating Facility's ability to provide any applicable Ancillary Services, provided that such studies and analyses have been or would be required in connection with the provision of such Ancillary Services by any existing Network Resource. However, if an Interconnection Customer's Large Generating Facility has not been designated as a Network Resource by any load, it cannot be required to provide Ancillary Services except to the extent such requirements extend to all generating facilities that are similarly situated. The provision of Network Integration Transmission Service or firm Point-to-Point Transmission Service may require additional studies and the construction of additional upgrades. Because such studies and upgrades would be associated with a request for delivery service under the Tariff, cost responsibility for the studies and upgrades would be in accordance with FERC's policy for pricing transmission delivery services. Network Resource Interconnection Service does not necessarily provide Interconnection Customer with the capability to physically deliver the output of its Large Generating Facility to any particular load on Transmission Provider's Transmission System without incurring congestion costs. In the event of transmission constraints on Transmission Provider's Transmission System, Interconnection Customer's Large Generating Facility shall be subject to the applicable congestion management procedures in Transmission Provider's Transmission System in the same manner as Network Resources. There is no requirement either at the time of study or interconnection, or at any point in the future, that Interconnection Customer's Large Generating Facility be designated as a Network Resource by a Network Service Customer under the Tariff or that Interconnection Customer identify a specific buyer (or sink). To the extent a Network Customer does designate the Large Generating Facility as a Network Resource, it must do so pursuant to Transmission Provider's Tariff. Once an Interconnection Customer satisfies the requirements for obtaining Network Resource Interconnection Service, any future transmission service request for delivery from the Large Generating Facility within Transmission Provider's Transmission System of any amount of capacity and/or energy, up to the amount initially studied, will not require that any additional studies be performed or that any further upgrades associated with such Large Generating Facility be undertaken, regardless of whether or not such Large Generating Facility is ever designated by a Network Customer as a Network Resource and regardless of changes in ownership of the Large Generating Facility. However, the reduction or elimination of congestion or redispatch costs may require additional studies and the construction of additional upgrades. To the extent Interconnection Customer enters into an arrangement for long term transmission service for deliveries from the Large Generating Facility outside Transmission Provider's Transmission System, such request may require additional studies and upgrades in order for Transmission Provider to grant such request.

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