Study Completion Date means the estimated or actual study completion date. Once the clinical trial has reached the study completion date, the responsible party must update the Study Completion Date data element to reflect the actual study completion date in accordance with§ 11.64(a)(1)(ii)(J) .Subpart B—Registration§ 11.20 Who must submit clinical trial registration information?The responsible party for an applica- ble clinical trial specified in § 11.22 must submit clinical trial registration information for that clinical trial.§ 11.22 Which applicable clinical trials must be registered?
Study Completion Date means the date the Study Director signs the final report. 2.4 Terms Concerning the Test Item1. Test item means an article that is the subject of a study.2. Reference item (“control item”) means any article used to provide a basis for comparison with the test item.3. Batch means a specific quantity or lot of a test item or reference item produced during a defined cycle of manufacture in such a way that it could be expected to be of a uniform character and should be designated as such.4. Vehicle means any agent which serves as a carrier used to mix, disperse, or solubilise the 88 test item or reference item to facilitate the administration/ application to the test system.
Study Completion Date means the date the study director signs the final report.
Examples of Study Completion Date in a sentence
The Study Completion Date is defined as the date the final subject, across all sites, completes their final protocol-defined assessment.
The Study Completion Date is used to ascertain timing for study results posting and reporting.
Again, Karla will be contacting and assisting study teams as their Primary Completion Date or Study Completion Date approaches.
In addition, it is likely that the Primary Completion Date and the Study Completion Date will have to be extended for paused studies.
Subject to the IND-Enabling Toxicology Study Completion Date and the Option Deadline, Biogen shall have the right to make the final decision regarding the timing and the order in which to conduct the IND-Enabling Toxicology Studies for Development Candidates.
More Definitions of Study Completion Date
Study Completion Date means the date the final report is signed by the study director.[43 FR 60013, Dec. 22, 1978, as amended at 52
Study Completion Date means the date the last observation is made at the time of the last study visit of the last patient who remains enrolled in a Combined Therapy Study at the planned completion of the Combined Therapy Study, or following a decision to terminate the Combined Therapy Study early, whichever happens first.
Study Completion Date means the date the final report is signed by the study director. [43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33779, Sept. 4, 1987; 54 FR 9039,Mar. 3, 1989; 64 FR 56448, Oct. 20, 1999; 67 FR 35729, May 21, 2002] § 58.10 Applicability to studies performed under grants and contracts. top When a sponsor conducting a nonclinical laboratory study intended to be submitted to or reviewed by the Food and Drug Administration utilizes the services of a consulting laboratory, contractor, or grantee to perform an analysis or other service, it shall notify the consulting laboratory, contractor, or grantee that the service is part of a nonclinical laboratory study that must be conducted in compliance with the provisions of this part. § 58.15 Inspection of a testing facility. top (a) A testing facility shall permit an authorized employee of the Food and Drug Administration, at reasonable times and in a reasonable manner, to inspect the facility and to inspect (and in the case of records also to copy) all records and specimens requiredto be maintained regarding studies within the scope of this part. The records inspection and copying requirements shall not apply to quality assurance unit records of findings and problems, or to actions recommended and taken. (b) The Food and Drug Administration will not consider a nonclinical laboratory study in support of an application for a research or marketing permit if the testing facility refuses to permit inspection. The determination that a nonclinical laboratory study will not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any applicable statute or regulation to submit the results of the study to the Food and Drug Administration. Subpart B—Organization and Personnel top § 58.29 Personnel. top (a) Each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions. (b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study. (c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol. (d) Personnel shall take necessary personal sanitation and h...
Study Completion Date means the date the final report is signed by the study director.
Study Completion Date means eighteen months after the Agreement Date, and is the date by which the study shall have been fully accomplished.
Study Completion Date means the date on which the last observation is made either of the last patient who remains enrolled in the Clinical Study or following a decision to terminate the Clinical Study early, whichever happens first.