Study Title. Set-Up and Pre-Validation of an HPLC Method for the Determination of BA058 and PTH in Dose Formulations SCOPE OF WORK DATED: November 14, 2008 PRICE: $1,900 US/Day (as per Study Authorization dated February 9, 2009) [*] % MPM discount included PAYMENT TERMS: · Monthly billing as per work performed. PROPOSED COMMENCEMENT OF WORK: February 2009 PROPOSED REPORTING TIME: Not applicable ACCLIMATION PERIOD: Not applicable RETENTION PERIOD: One (1) year STUDY MATERIAL STORAGE/ARCHIVES. After dispatch of the draft report, all raw data, samples/specimens (except for those sent to Sponsor or Sponsor designated laboratory and resultant data which are the responsibility of Sponsor) and documents generated at Xxxxxxx River Montreal during this study, together with the original copy of the protocol (including amendments) and the draft report, will be retained in the secure storage area of Xxxxxxx River Montreal for one (1) year at no charge. After this one (1’) year period, Sponsor will be contacted prior to the end of the year to authorize continued storage or return to Sponsor, at additional cost. At finalisation, the final report and any stored materials will be transferred to the scientific archives of Xxxxxxx River Montreal. Subsequently, storage details will be documented in the raw data. Any additional storage, archiving or retention will require an Extended Archiving Agreement DELAY IN PRECLINICAL WORK. In the event that any animals are purchased by Xxxxxxx River Montreal, as authorized by and on behalf of the Sponsor, for preclinical work to be performed under this Letter of Agreement, the parties hereto agree that the acclimation period (“Acclimation Period”) shall be stipulated herein. After the completion of the Acclimation Period, should there be any delay in the commencement of the Study that is attributable to the Sponsor, in any way, then the Sponsor agrees to reimburse housing fees to Xxxxxxx River Montreal for the said delay at rates prevailing at the time of said delay.
Study Title. [Insert SHORT TITLE OF STUDY] Reference: [Insert REFERENCE NUMBER e.g. IRAS, EUDRACT NUMBER OR SIMILAR REFERENCE]
Study Title. Validation of an HPLC Method for the Determination of BA058 and PTH in Dose Formulations SCOPE OF WORK DATED: To be provided PRICE: $21,850 US (as per Study Authorization dated February 9, 2009) [*] % [*] discount included PAYMENT TERMS: 50% - $10,925 US - 1st installment at commencement of laboratory work 50% - $10,925 US - 2nd installment at completion of laboratory work (excluding long term stability testing, if applicable) PROPOSED COMMENCEMENT OF WORK: March 2009
Examples of Study Title in a sentence
Study Title) of the Requirements Status and Registrant's Response form.
Include the Study Title This study has been explained to me and any questions I had have been answered.
Protocol No. Study Title : Name of Principal Investigator : Type of COI (Personal/ Professional/Financial) and the Reason : Hence, I stay away from reviewing this research proposal, any deliberations/discussions on this study, and refrain from any decision making.
Study Title: (The title should accurately reflect the purpose of the study.
Case Study Title (Case Study):Case Study #1, Alpine Ski HouseOverviewAlpine Ski House operates ski resorts that provide accommodations, dining, and entertainment to customers.The company recently acquired four resorts from Contoso, Ltd.
More Definitions of Study Title
Study Title. IRB #: The above-named Unaffiliated Investigator has reviewed the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research; the U.S. Department of Health and Human Services (DHHS) regulations for the protection of human subjects at 45 CFR 46, the Assurance referenced above, and the relevant institutional policies and procedures for the protection of human subjects.
Study Title. Screen hENT1 antibody for suitability on Ventana’s automated system. • Study Identification: Clovis hENT1 BIOMARKER PROJECT
Study Title. [TITLE] [SPONSOR_PROTOCOLS] This confirms that an IRB Authorization Agreement with the organization identified above has been executed to rely on their IRB for continuing oversight of this study. This agreement specifies the roles and responsibilities of the respective entities. [DESCRIPTION] [SUBMISSION_DESCRIPTION] [FINDINGS] It is your responsibility to: SAMPLE ONLY
Study Title. (the “Study”): “A Placebo-controlled, Multi-center, Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of ORMD-0801 in Type 2 Diabetes Mellitus Patients with Inadequate Glycemic Control on Oral Therapy” Protocol: # (the “Protocol”): ORA-D-015, Amendment #3 dated April 4, 2019
Study Title. (the “Study”): “A Placebo-controlled, Multi-center, Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of ORMD-0801 in Type 2 Diabetes Mellitus Patients with Inadequate Glycemic Control on Oral Therapy” Protocol: # (the “Protocol”): ORA-D-015, Amendment #3 dated April 4, 2019 Purpose of Amendment: Revise the contract to reflect two Protocol Amendments, which includes the following changes: ● Subject number has increased as follows ○ Cohort A (the original contract through Protocol Amend #2) increased from 445 screened to 545 screened ○ Cohort B (added in Protocol Amend #3) added 145 patients screened [+] ● Sites: ○ Cohort A: 39 Sites ○ Cohort B: 26 Sites ● Protocol Amendment 1,2 added the activities below: ○ Writing of 2 Protocol Amendments ○ Writing of 2 ICF Amendments ○ 8-month delay in timeline increasing project management, site management, medical monitoring, data management and EDC support management ■ a 3.5-month enrollment hold due to a drug delay ■ a 4.5 month increase in enrollment due to limited drug supply and addition of placebo arm ○ Regulatory processing of 2 Protocol Amendments, IRB submission ○ Creation of CSA amendments for the sites ○ Creation of 23 additional eCRF pages to replace electronic diary, screen programming and UAT testing ○ Increased eCRF pages per complete subject from 106 to 129 increasing data management tasks ○ Increase in EDC platform fees for 8 months ○ Increase in printing to print paper diaries Amendment #1 to Oramed Clinial Research Organization Services AgreementProtocol # ORA-D-015 1 Integrium, LLC. Confidential ● Protocol Amendment #3 added the activities below: ○ Writing of 1 Protocol Amendment ○ Regulatory Processing of 1 Protocol Amendment, IRB submission ○ Revision of the IWRS system causing a 1.5-month screening delay ○ Addition of 3 months of enrollment to enroll the subjects as stated above in 26 active sites ○ Increase in the number of monitoring visits to monitor the additional subjects ○ Separate Database lock for Cohort A and an additional lock for Cohort B ○ Revision to the SAP and the increase in SAS datasets and TLGs, per Xxx ○ Increase in Investigator Grants ○ Increase in IRB processing pass-through fees ○ Increase in EDC platform fees for 4.5 months Study Timeline: Study timeline increased by 12.5 months ● Cohort A: 8 months ● Cohort B: 4.5 months
Study Title. A Phase 1b/2, Open-Label, Název klinického hodnocení: „Otevřená Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3XCD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter’s Syndrome Protocol no.: GCT3013-03 studie fáze 1b/2 hodnotící bezpečnost a účinnost přípravku epcoritamab (GEN3013; DuoBody®-CD3 X CD20) u pacientů s relabující/refrakterní chronickou lymfocytickou leukémií a Richterovým syndromem” Č. protokolu: GCT3013-03
Study Title. A Prospective Randomized Placebo Controlled Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine in Subjects with Hypertension Requiring Antihypertensive Therapy PROTOCOL NO.: K-302-03-01 PROPOSED ALLOCATION OF SPONSOR - JAVA- DUTIES AND FUNCTIONS 04 FEBRUARY 2014 I. Regulatory and Ethics II. Investigator Relations III. IMP Supplies IV. Study Documentation