CLINICAL CORE The three research projects proposed within the framework of the CIDEIM TMRC program, each with different but complementary approaches towards optimizing surveillance and treatment for control of cutaneous leishmaniasis, require enrollment of human participants. The Clinical Core will assure the ethical planning, implementation and monitoring of inclusion of human subjects and throughout the conduct of each TMRC research project. The purpose of this Core is to provide the logistic, human resource, technical and infrastructural support needed to conduct the clinical component of each project, while assuring compliance with national and international ethical, Good Health Research Practice (GHRP), and Good Clinical Laboratory Practice (GCLP) standards. Implementation Research principles and practices will also be integrated transversally into the TMRC program and further strengthen the institutional capacity for clinical and public health research. This goal will be achieved through the following Specific Aims 1. To provide clinical, laboratory and logistic support for the diagnosis, recruitment, treatment and follow-up of participants of the TMRC program. 2. Guarantee the application of GHRP, ethical conduct and GCLP guidelines to Clinical Core operations and in the conduct of the three TMRC research projects. 3. Ensure that the three TMRC research projects are conducted, recorded, and reported in accordance with the protocol, Standard Operating Producers (SOP), GHRP, and applicable regulatory requirements. 4. Strengthen capacity within CIDEIM and study sites in clinical research and implementation research. The Clinical Core team will develop standard operating procedures and will coordinate training of involved personnel to ensure systematic execution of clinical and laboratory procedures. Additionally, in collaboration with the project PIs, the Clinical Core will facilitate the layout of strategic plans to enroll patients, and minimize risk of sample loss or compromise considering the nature of the samples and possible geographical and infrastructural limitations at field sites. This practice recognizes and values participant efforts and cooperation to provide samples, while maximizing sample integrity and avoiding invalidation of data. The proposed quality assurance and capacity strengthening of clinical and health personnel in CIDEIM Cali and Tumaco and field study sites will improve the quality of health care for CL patients in the endemic sites, and will feed into the clinical research training program for medical graduates and clinical research fellows, thereby contributing to the development of a critical mass of independent Colombian researchers who appreciate the importance of ethics and good research practices, and understand how assure compliance with these guidelines in their own research.
