Study Site Clause Samples

Study Site. The Study should be conducted at ________________. The Site will provide the human resources included in its normal activity in the execution of the Study. Biobizkaia will invoice the Sponsor for all costs incurred in the Study, except for the compensation to the investigation team (if there is no express indication by the Principal Investigator). The financial arrangements will be detailed in the Payment Schedule attached as Annex II of this Agreement, as an inseparable part of it. It will include, thus: Costs for managing the Agreement The amount of ________________ + VAT (Table I of Annex II) is established to be paid for management of the Agreement and the payment will be made on presentation of the corresponding invoice at the same time that the Agreement is ready for signatures. In multicentre studies a single payment will be made for this item. The total amounts to be paid will be calculated according to the table published by ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇. Costs of running the Study. (Invoice will be prepared to pay Biobizkaia only) The amount of ________________ plus taxes (if applicable), will be paid per completed patient (Table II of Annex II). Biobizkaia will distribute the payments as follows: 10% of the Study total will be assigned to Biobizkaia to defray the cost incurred in the managing the running of the Study. The remaining costs will be distributed as follows: 30% will be assigned to the site investigator to promote research (Table II of Annex II). 70% will be assigned to the investigator team. (Table II of Annex II). (Option 1) As indicated by the Principal Investigator, said amount thereof shall be paid directly to Biobizkaia for reinvestment in the R & D activities of the Investigator or the Research Team. (Option 2) This compensation will be reimbursed directly by the Sponsor to the Investigator Team, in the account designated by the PI or following the indications of the invoice issued. In those studies that due to their size or by being considered an area of special interest or impact for the Basque Country Health System, in the negotiating of the Agreement Biobizkaia reserves the legal authority to adapt or adjust the distribution of the chargeable invoice amounts. Form of payment The calculation of the amount of work done in the Study for invoicing purposes will be notified to Biobizkaia by the Sponsor and in parallel by the Principal Investigator, so that Biobizkaia may submit the corresponding invoices, after having verified the details...

Study Site. A. General Information Field work for this project took place in Cimarron County, Oklahoma, just north of Kenton, Oklahoma at The Nature Conservancy/Oklahoma State Parks Black Mesa Preserve. The areas surveyed included shortgrass prairie and Juniperus monosperma woodland habitats. Soil types encountered included Apache stony clay loam, Berthoud loam, Rough stony land, and Travesilla stony loam. Species encountered included Aristida spp., Buchloe dactyloides, Bouteloua curtipendua, B. gracilis, B. hirsuta, Chaetopappa ericoides, Comandra pallida, Dalea formosa, Echinocereus viridis, Melampodium leucantheum, Opuntia imbricata, O. polyacantha, O. phaeacantha, Tetraneuris scaposa, and Yucca glauca. These habitats, soils, and species are all known to be associated with populations of Asclepias uncialis.

Study Site. Interviews were all conducted within the city of Nairobi, Kenya, and those sampled were all currently living and working in Nairobi, although some had had EMS experience in other parts of Kenya. Nairobi, the capital of Kenya, represents all ethnic groups and religions present in Kenya (CIA, 2012). The most recent data shows that Nairobi hosts over 3 million residents, making it the largest city in Kenya (CIA, 2012). This does not take into account the estimated almost 1 million people who live in the various slums contained within the Nairobi city limits. Nairobi was chosen for the study site because all major EMS companies are based out of Nairobi, and all government offices are there as well. Additionally, all EMT training takes place in Nairobi and the majority of the country’s ambulances are stationed throughout the city. Therefore, it hosts the most concentrated number of people who are actively involved in EMS development and who meet the criteria for the population studied. Interviews mostly took place in the location of the interviewees’ jobs, but sometimes were conducted in coffee shops and cafes before the workday started. Although there was a questionnaire used to guide the interview process, interviews were conducted informally with a pen and paper to record responses, in hopes to not intimidate the interviewees and to provide a relaxed and open environment that would encourage honest conversation.

Study Site. Arm 1 ‐ Intervention 1 (Improved IYCF + Reduced Exposure to Feces) 79

Study Site. This study used data collected from the SaniPath Study in four low-income neighborhoods in Accra, Ghana between September 2011 and March 2013 in collaboration with the Water Research Institute of the Center for Scientific and Industrial Research Institute, Ghana (WRI), The Noguchi Memorial Institute for Medical Research of the University of Ghana (NMIMR), and the Training, Research, and Networking for Development (TREND) Group. The SaniPath Study was conducted to quantify the relative contributions of various household- and neighborhood- level risks of exposure to fecal contamination through multiple environmental pathways. Accra has two rainy seasons, March – July and September – October, each year. Soil and drain samples were collected from March – December 2012, and household surveys were conducted from August – September 2012. Public toilet surveys were conducted from March – September 2012. Though all were low-income areas, the four study neighborhoods (Alajo, Bukom, Old Fadama, and Shiabu) were selected for variation in types of settlements, location, flooding, and household and public sanitation coverage.86,113 Further details on neighborhood selection and characteristics are described elsewhere.86,113 All study protocols were approved by the Institutional Review Board (IRB) at Emory University and the NMIMR IRB, University of Ghana. Samples of soil in public places and water in open public drains were collected in each neighborhood. As directed by community leaders and local field staff, locations for sample collection were purposefully selected where children were observed to have been playing or had contact with drains. Global Positioning System (GPS) coordinates were collected at each location at the time of sampling using a Garmin eTrex Venture HC device (Garmin Ltd., Olathe, KS, USA). Samples were tested for E. coli, adenovirus, and genogroup I and II norovirus (GI and GII norovirus). E. coli was chosen as a general indicator of fecal contamination, while adenovirus and norovirus were chosen because of their high infection burden in recent studies of West African children.16,96,147,148 Samples were tested for E. coli by membrane filtration using BBL MI agar (Becton ▇▇▇▇▇▇▇▇▇, Franklin Lakes, New Jersey, USA) following United States Environmental Protection Agency (USEPA) method 1604.149 For virus analyses, DNA and RNA extraction utilized the MP Bio FastSoil DNA kit (MP Bio, Santa Ana, CA, USA) and Qiagen viral RNA mini kit (Qiagen Sciences, Ge...

Study Site. The trial shall be conducted at ………… of the Hospital Universitari Vall d' Hebron , Barcelona.

Study Site. The village of Calhuitz in the municipality of San Sebastián Coatán in the department of Huehuetenango lies high in the mountains of Guatemala‘s western highlands. The residents of Calhuitz are indigenous Maya Chuj, the majority of whom practice Catholicism and are agriculturalists, many practicing subsistence agriculture and living in relative poverty. The village is very remote, approximately five hours in private vehicle from the departmental capital of Huehuetenango, where the closest national hospital is located, and transportation is limited with but one, daily round trip to Huehuetenango leaving at 4:00 a.m. While Calhuitz has no paved roads, it does have electricity and piped plumbing although the water is not potable and must be treated at point of use for safe consumption. The village has few shops that provide some basic necessities such as eggs, corn flour, and toilet paper. To purchase most of their consumer and food products, residents will either walk or bus a few kilometers downhill to the town of San ▇▇▇▇ Pueblo Nuevo which has various stores and an open air market every Friday, the only day with regular microbus transportation between Calhuitz and San ▇▇▇▇. There is one community pharmacy located in Calhuitz which is adjoined to the Casa Materna maternity clinic. The Casa Materna (CM) serves not only the community of Calhuitz, where it is located, but also 25 surrounding communities. The services they provide include weighing and counseling of children, vaccination, supplementation, prenatal consults, family planning, health education for children and community members, continuing education for traditional birth attendants (TBAs), and general consults and emergency care at the clinic in addition to child delivery. The majority of newborns in Calhuitz are delivered at the CM with the assistance of the nurses and a TBA while the children in the surrounding communities are usually delivered in the home assisted by a TBA.

Study Site. Arm 1 - Intervention 1 This bit (in reference to ‘homestead food production’) should be stronger for improved production and its links to nutrition both from dietary diversity and improved purchasing power.

Study Site the medical institution Detska nemocnice - Klinika detske neurologie, ▇▇▇▇▇▇▇▇▇▇ ▇, ▇▇▇ ▇▇ ▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, which is a place, where this Study is conducted, and which complies with respective regulations of the Czech Republic. (Hereinafter referred to as „INSTITUTION”).