Clinical Protocol Sample Clauses
Clinical Protocol. (a) NCI will facilitate the solicitation and receipt of ▇▇▇▇ for clinical research, contemplating the use of Collaborator’s Formulary Agents. NCI will require potential Sponsors to complete a “Letter of Intent” (“LOI”). NCI will provide Collaborator with a copy of any LOI submitted which requests use of Collaborator’s Formulary Agents, which contains a summary of the draft clinical protocol including the proposed statistical analysis plan for the Study and, estimated funding from the Collaborator to support the Study.
(b) Within 60 days of receipt of a Letter of Intent from NCI, Collaborator shall provide a written notice to IC whether or not it approves the LOI. Acceptance of an LOI shall be Collaborator’s sole discretion. • If Collaborator notifies NCI of its rejection of the LOI within such 60-day period, then neither Party shall have any obligations to the other with respect to the proposed Study or any drug supply in respect of such Study. • If Collaborator notifies NCI within such 60-day period that it approves the LOI with a signed drug approval form, the Approved Investigator will draft and submit a full clinical Protocol(s) for approval by Collaborator. • Following the LOI approval, the Parties (or their respective designated Affiliate) will, as soon as reasonably practicable following such notification, arrange communications between PMB staff and Collaborator supply personnel to discuss logistics. • Any changes to the Protocol shall require Collaborator’s prior written consent. Any such proposed changes will be sent in writing to Collaborator by Approved Investigator.
Clinical Protocol. Clinical protocol proposals for each study within the scope of the CRADA Research Plan will be solicited from selected intramural and extramural clinical investigators. Each clinical protocol should describe in detail the research to be conducted and must DC submitted to the PRC for approval prior to implementation. Each clinical protocol received by NCI will be forwarded to Collaborator for review and comment approximately two weeks before it is reviewed by the PRC. Comments from Collaborator received by CTEP before the PRC meeting will be discussed by the PRC, will be given due consideration, and will be incorporated into the protocol, absent good cause. Comments from either Collaborator or the CTEP staff that are agreed upon in the PRC meeting will DC formatted as a consensus review, which is returned to the investigator for necessary and/or suggested changes before the protocol can DC given Final approval and submitted to the FDA. A copy of the final approved protocol will be forwarded to Collaborator at the same time as it is submitted to the FDA. NCI protocol #00-C-0050 (P-92), entitled ‘Phase 3 Randomized Study of Autologous Lvmphoma Derived Idiotype Specific Vaccination Plus Sargramostim (GM-CSF) in Patients with Indolent Follicular Lvmphoma in First Complete Remission’ will be transferred to Collaborator upon FDA approval of Collaborator’s IND application.
Clinical Protocol. Biodel shall furnish to Aegis a copy of the clinical protocol and the related patient informed consent form for any clinical trial study, which involves an Enhancement Agent or the Aegis Technology; and Aegis shall be entitled to share such documents with the Aegis insurance carriers to the extent required to comply with its contractual obligations to such entities. Aegis agrees that any personally identifiable information or protected health information, which comes into Aegis’ possession under this License Agreement will be protected and acted on in accordance with applicable data protection legislation, such as the Health Insurance Portability and Accountability Act of 1996 as well as all other applicable laws and regulations.
Clinical Protocol. First the GH secretory reserve was assessed by three stimulation tests in addition to the ITT, and subsequently spontaneous GH secretion was measured during 24h with blood sampling intervals of 10 minutes. The GH stimulation tests were carried out in random order on separate days (during a two- week period) in the fasting condition. The following tests were performed: the GHRH test (Fer- ring, Hoofddorp, The Netherlands: 1 μg/kg body weight by i.v. bolus injection, blood samples drawn at 0, 20, 30, 45, 60 and 90 min), the l-arginine infusion test (500 mg/kg body weight with a maximum of 30 g, infusion during 30 minutes, blood samples drawn at 0, 30, 45, 60, 90 and 120 min), and the combined GHRH-arginine test as an i.v. bolus injection of GHRH (1 μg/ kg body weight) after which l-arginine (500 mg/kg body weight with a maximum of 30 g) was infused during 30 minutes, blood samples drawn at 0, 30, 45, 60, 90 and 120 min. The peak serum response of GH was used as the primary variable for analysis of stimulation tests. For the 24h sampling study, the patients were admitted to the Clinical Research Center in the morning. An indwelling i.v. cannula was inserted in a forearm vein at least 60 min before sampling began. Blood samples were withdrawn at 10 min. intervals for 24h, starting at 09.00h. A slow infusion of 0.9% NaCl and heparin (1 U/ml) was used to maintain patency of the i.v. catheter. The subjects were not allowed to sleep during the daytime. Meals were served at 09.00, 12.30 and 17.30h. Lights were turned off between 22.00-24.00h. Plasma samples for GH measurements were collected, centrifuged at 4°C for 7 minutes, and stored at –20°C until later analysis. Assays GH concentrations in the samples of the stimulation tests were measured by time resolved immunofluorometric assay (Wallac, Inc, Turku, Finland). Reference values, listed in the tables and main text were obtained with the same assay. Human biosynthetic GH (Pharmacia and Upjohn, Inc, Uppsala, Sweden) was used as standard, calibrated against WHO-IRP 80-505 and the detection limit of this GH assay is 0.01 μg/l with an interassay coefficient of variation of 1.6-8.4%, between 0.1 and 15 μg/l (1 μg/l = 2.6 mU/l). GH concentration in the serum samples of 24h profiles of the patients in this study were measured with the more sensitive automatic immunochemiluminescence assay (Nichols Diagnostics Institute, San Clemente, CA), using 22 kDa rhGH as standard. Cross reactivity with 20kDa GH was 30%. Assay sens...
Clinical Protocol. Effective April 29, 2004, NCI protocol #00-C-0050 (P-92), entitled ‘Phase 3 Randomized Study of Autologous Lymphoma Derived Idiotype Specific Vaccination Plus Sargramostim (GM-CSF) in Patients with Indolent Follicular Lymphoma in First Complete Remission’ will be conducted under Collaborator’s IND application # 5427.
Clinical Protocol. IC will facilitate the solicitation and receipt of proposals for clinical research, contemplating the use of Collaborator’s Formulary Agents. IC will require potential Sponsors to complete a “Letter of Intent” (“LOI”). IC will provide Collaborator with a copy of any LOI submitted which requests use of Collaborator’s Formulary Agents, which contains a summary of the draft clinical protocol including the proposed statistical analysis plan for the Study, and estimated funding from the Collaborator to support the Study.