Essential Documents definition
Essential Documents means documents which individually and collectively permit evaluation of the conduct of the Study and the quality of the data produced. GCP Guideline means the Committee for Proprietary Medicinal Products (CPMP)/International Conference on Harmonisation (ICH) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) as adopted with annotation by the TGA, as amended from time to time.
Essential Documents means documents which individually and collectively permit evaluation of the conduct of the Study and the quality of the data produced.
Essential Documents means documents which individually and collectively permit evaluation of the conduct of the Study and the quality of the data produced. Good Clinical Practice (GCP) means the procedures and practices described in ISO 14155:2003 Parts 1 and 2.
Examples of Essential Documents in a sentence
The Authorizer its designee(s) or legal counsel, however, may conduct such monitoring activities in its performance review as it deems appropriate to ensure that the School is complying with applicable law, the terms of this Contract and Essential Documents.
As referenced above, these Performance Frameworks and the annual performance indicators are part of the Essential Documents governing the Parties.
The Contract and Essential Documents to this Contract contain all terms, conditions, and understandings of the Parties relating to its subject matter.
The School must first vote in a public meeting to approve any proposed amendment to the Contract or Essential Documents.
The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product, Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site.
More Definitions of Essential Documents
Essential Documents as defined in Chapter 8 of ICH-GCP that are Controlled by Ardelyx relating to the Lead Licensed Compound and Lead Licensed Product (the “Essential Documents”). Ardelyx will have the right to retain original copies of the foregoing but shall make such original copies available to AstraZeneca at Ardelyx’s site of business upon reasonable advance written notice by AstraZeneca.
Essential Documents means documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced;
Essential Documents the Research and the documents necessary to confirm that the quality of the BBEST Information is consistent with Sections 8.1 to 8.4 of ICH Good Clinical Practice ("GCP") .
Essential Documents means documents which individually and collectively permit evaluationof the conduct of a study and the quality of the data produced; “ethical clearance” means an authorization to conduct a clinical trial issued by an approved institutefor medical research; “good clinical practice” means a standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provide assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of study participants areprotected; “good manufacturing practice” means that part of quality assurance which ensures that investigational medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketingauthorization; ‘‘herbal drug'' means any labeled preparation in pharmaceutical dosage form that contains one or more substances of natural origin as activeingredients that are derived from plants; “informed consent” means participant voluntaryconfirmation of willingness to participate in a particular trial, and the documentation thereof; “inspection” means the act of conducting an official review of documents, facilities, records, and any other resources that are deemed by the Authority to be related to the clinical trial andthat may be located at the clinical trial site; “investigational medicinal product” in relation to a drug, medical device and herbal drug means a pharmaceutical form of an active ingredient orplacebo being tested or used as a reference in a clinical trial, including a product with a
Essential Documents mean all of those documents defined by Section 8 (Compensation) of the ICH Guidelines.
Essential Documents means a document (including, but not limited to, electronic data) that shall be allocated as the following case as may be: a) with respect to the documents related to Clinical Studies of the Products as required for the grants of Market Authorisations in the Territory shall be described and duly marked as an "Essential Document" in EXHIBIT D-1; b) with respect to the documents related to Clinical Studies of the Products which are conducted post-marketing approval in the Territory shall be described as set forth in Section 4.3 of the Agency and Distribution Agreement. related to Clinical Studies of the Products described and duly marked as an “Essential Document” in EXHIBIT D-1. The definition of “Product(s)” shall be deleted in its entirety and replaced with the following:
Essential Documents means those essential documents defined in ICH Guideline E6, Section 8 and as required by Applicable Law (including Case Report Forms, Investigator files, regulatory files, minutes of Project Team meetings, and any other core Study documentation agreed to in writing by the Parties as detailed in the Study Project Plans).