Ethics Committee Review; Informed Consent Form Sample Clauses

Ethics Committee Review; Informed Consent Form. 1.2.1 Site shall coordinate with the Ethics Committee for Multicentrics Trials (“ECMT”) and local Ethics Committees (“LEC”) (jointly, Ethics Committees or “EC”) with a view towards obtaining the EC approval of the conduct of the Study at Institution, and provide Sponsor and CRO with copies of such approval, and all relevant correspondence with the EC.
Sample 1
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Ethics Committee Review; Informed Consent Form. 1.2.1 Site shall coordinate with the Ethics Committee for Multicentrics Trials (“ECMT”) and local Ethics a Správnou klinickou praxí Místo provádění klinického hodnocení souhlasí s tím, že Místo provádění klinického hodnocení a Studijní personál provede ve Zdravotnickém zařízení Studii v přísném souladu s touto Smlouvou, Protokolem, veškerými příslušnými právními předpisy a nařízeními, zejména včetně GCP, zák. č. 378/2007 Sb., o léčivech a změnách některých souvisejících zákonů („Zákon o léčivech“) a Vyhlášky č. 226/2008 Sb., o správné klinické praxi a bližších podmínkách klinického hodnocení léčivých přípravků, v platném znění, zák. č. 372/2011 Sb., o Zdravotních službách a podmínkách jejich poskytování („Zákon o zdravotních službách“) nebo jakýchkoli následných pozměňujících či podstatně nahrazujících právních předpisů ve vztahu ke shora uvedeným právním normám, (společně „Příslušné právní předpisy“) a příslušných předpisů na ochranu osobních údajů („Právní předpisy na ochranu osobních údajů“). Místo provádění klinického hodnocení tímto bere na vědomí, že CRO a Zadavatel, a jejich odpovědné pobočky, se zavazují dodržovat předpisy vydané americkým úřadem Food and Drug Administraton („FDA“) nebo jakýmikoli jiným příslušným úřadem, včetně federálního zákona č. 21 C.F.R, § 11, 50, 54, 56, 312 a 1301 – 1304. Místo provádění klinického hodnocení a studijní personál tímto berou na vědomí, že CRO a Zadavatel a jejich odpovědné pobočky jsou povinny dodržovat
Sample 1

Related to Ethics Committee Review; Informed Consent Form

  • Additional RO Review Criteria (1) In addition to the requirements in Subparagraph 34A, the RO must:

  • EMPLOYEE PERFORMANCE REVIEW AND EMPLOYEE FILES 39.01 For the purpose of this Article,

  • Claims Review Findings a. Narrative Results.‌‌

  • Office of Inspector General Investigative Findings Expert Review In accordance with Senate Bill 799, Acts 2021, 87th Leg., R.S., if Texas Government Code, Section 531.102(m-1)(2) is applicable to this Contract, Contractor affirms that it possesses the necessary occupational licenses and experience.

  • Ongoing Review and Revisions As set forth in Section 35.7, the Parties have agreed to the coordination and exchange of data and information under this Agreement to enhance system reliability and efficient market operations as systems exist and are contemplated as of the Effective Date. The Parties expect that these systems and the technology applicable to these systems and to the collection and exchange of data will change from time to time throughout the term of this Agreement. The Parties agree that the objectives of this Agreement can be fulfilled efficiently and economically only if the Parties, from time to time, review and, as appropriate, revise the requirements stated herein in response to such changes, including deleting, adding, or revising requirements and protocols. Each Party will negotiate in good faith in response to such revisions the other Party may propose from time to time. Nothing in this Agreement, however, shall require any Party to reach agreement with respect to any such changes, or to purchase, install, or otherwise implement new equipment, software, or devices, or functions, except as required to perform this Agreement.

  • Technical Objections to Grievance No grievance will be defeated or denied by any minor technical objection.

  • Committee Work All time spent by employees on Employer established committees and committees mentioned in this contract (including side letters) shall be considered time worked and shall be paid at the appropriate rate of pay. Time spent on committee work will not be counted towards the calculation of overtime.

  • Training Committee The parties to this Agreement may form a Training Committee. The Training Committee will be constituted by equal numbers of Employer nominees and ETU employee representatives and have a charter which clearly states its role and responsibilities. It shall monitor the clauses of this Agreement which relate to training and ensure all employees have equal access to training.

  • Personnel File Review a. A unit member has the right upon his/her own request to review the contents of his/her personnel file. The review will be conducted in the presence of the administrator, or his/her designee, responsible for the safekeeping of such file. The employee may have a committee person assist in said review. Such review shall be conducted at a mutually agreeable time. A copy of requested material will be provided.

  • Technical Objections to Grievances It is the intent of both Parties of this Agreement that no grievance shall be defeated merely because of a technical error, other than time limitations in processing the grievance through the grievance procedure. To this end, an arbitration board shall have the power to allow all necessary amendments to the grievance and the power to waive formal procedural irregularities in the processing of a grievance, in order to determine the real matter in dispute and to render a decision according to equitable principles and the justice of the case.

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