Study Sites. CRO will use best efforts to assure that all study sites perform the Study in accordance with the Agreement.
Study Sites. The DMFs are currently installed in six government-run district hospitals across six regions in Ghana (Figure 4): Bole District Hospital in the Northern Region, Kintampo District Hospital in the Xxxxxx-Ahafo Region, Mampong-Asante District Hospital in the Xxxxxxx Region, Kete-Kratchi Government Hospital in the Volta Region, Apam Catholic Hospital the Central Region, and Axim Hospital in the Western Region. These district-level hospitals serve both urban and rural populations of between 100,000 and 200,000 people and use a centralized water distribution systems provided by their respective municipalities.
Study Sites. Interviews were conducted in three locations in private offices: (1) the Adult Grady Behavioral Outpatient Center (Outpatient Center) at Xxxxx Memorial Hospital, located at 00 Xxxx Xxxxx XX, Xxxxxxx, XX; (2) Xxxxxxxxx Healthcare, located at 0000 Xxxxxx Xxxx Road Atlanta, GA; and (3) Xxxxx Hospital, located at 00 Xxxxx Xxxx Junior Drive SE, Atlanta, GA. The Outpatient Center serves as the outpatient psychiatric care center for Atlanta’s safety net hospital.
Study Sites. We measured present and historical soil bed level dynamics in different estuarine habitats across five European estuaries from three different regions, distributed along a latitudinal range: the Mondego estuary, in Coimbra (Portugal); the Santoña Marshes estuary, the Xxxxx (Bay of Santander) and Oyambre estuary in Cantabria (Spain); and the Western Scheldt in Zeeland (The Netherlands) (Figure 1). All estuaries except Oyambre are fed by relatively large rivers. On the contrary, Oyambre is mainly fed by surficial runoff and the input of small creeks, among which Río Turbio that flows into the east branch, is the largest. In order to reflect differences in sedimentation patterns associated to variability in the river and tidal flow, we considered different estuarine sections, from inner areas to areas closed to the estuary mouth. We considered both vegetated habitats and tidal flats, inhabited by macro benthos, which have received much less attention than vegetated communities (e.g. saltmarshes) despite being critical ecosystems in the estuary (e.g. providing food for migratory species). We analysed the relationship of sedimentary vs. erosional trends with natural (e.g. wind) and anthropogenic factors (e.g. xxxxx) in order to understand the long-term tendency of the estuarine communities and their potential for carbon sequestration and coastal protection in the long-term.
Study Sites. The study was conducted in communities surrounding DSI’s Gadyen Dlo’s Léogâne, Jolivert and the North Parish programs (see Figure 3). Figure 3 DSI Program Sites and Household Coverage in Communities Served Figure from (Xxxxxx, 2012b)
Study Sites. EUSwitzerland – 1 site German – 6 sites total Ireland – 3 sites United Kingdom – 5 sites Belgium – 1 site France – 5 sites The Netherlands – 2 sites FDA Agreements Post-Marketing Study (Sky0101-010) • Objectives of Post-Marketing Study • Fulfill FDA post-marketing requirement (all patients) • NDA expedited review of surrogate endpoint pivotal LM study based on CSF clearance of malignant cells • Patient population: lymphomatous meningitis and solid tumor • Primary endpoint neurological progression free survival • Expand label (STNM Subgroup of patients) • Current NDA indication lymphomatous meningitis • Add solid tumor neoplastic meningitis • Expand study to include European study sites • Improve enrollment • Pooling of US and European data acceptable • Differences in patient management acknowledged by FDA • One significant pivotal study sufficient for STNM approval • P<.0366 for each of two independent primary efficacy analysis • Enroll patients until 72 events occur in STNM subgroup • Event driven analysis • Interim sample size adjustment net necessary • 67% of patient enrolled are STNM • >90% of patients will have an event prior to 2-yr. follow-up • Approximately 110 additional patients will be enrolled • Enrollment complete 2H’04 • As of 18 December 2002 • 42 Patients Randomized • 12 lymphoma patients • 30 solid tumor patients • Regulatory Filings • US • Pre-supplemental NDA meeting 1Q2005 • NDA 2Q2005 • Europe • Pre-MAA Meeting 1Q2005 • Scientific Advice 1Q2005 • MAA (EU) 2Q2005
Study Sites. The DMID, NIAID will utilize trial sites under Government Contract for the studies described in the protocol. The NIAID will ensure that the protocol will be conducted at Clinical Trial Sites according to the U.S. FDA Good Clinical Practices Guidelines.
Study Sites. MGH will negotiate and sign clinical research site agreements with the participating Study sites (“Site”) in the form and substance similar to the template attached hereto as Exhibit B (“Site Agreement”). The template shall provide, in part:
Study Sites. Each study site and investigator proposed by Ascent for participation in the study must be approved by Unicycive prior to initiation of any on-site study-related activities involving that study site or investigator. Following receipt of such approval by Unicycive, Ascent will assist with negotiation and execution of a clinical trial agreement with each such investigator in the form approved by Unicycive. Unless otherwise specifically requested by Unicycive in writing or required under Applicable Law, Ascent will not contract directly as a party to any clinical trial agreements with participating study sites. The clinical trial agreements and any modifications thereto shall be subject to the written approval of Unicycive prior to any use thereof.
Study Sites. The reference benthic communities belong to two EASIZ Programme key-sites, for which a background knowledge already exists and from which important study material is available:
