Clinical Study Start-Up: Overview of the Process and Expected Challenges
Journal Title: Journal of Clinical and Medical Research - Year 2020, Vol 2, Issue 2
Abstract
Start-up phase is the base of any project at any type of business, and CROs are not an exception. Initially, the emphasis was concentrated on conducting the study, with little attention paid to study start-ups (SSUs), but as stakeholders become more and more aware that the effectiveness of SSU processes is directly related to shorter clinical periods, interest in this opportunity is growing. SSU covers a lot of activities starting from sites identification and completing the enrollment of the first patient - in between this includes site selection and pre-study visits, trial documents submission to competent authorities, contract and budget execution, vendors approval and setup, site activation, site initiation visits and, at last, enrolling the first patient. Each step has multiple components and requires utmost care and attention to minimize the likelihood of study delivery delays from the beginning.
Authors and Affiliations
Olena Barabash*
Keywords
Related Articles
- EP ID EP708387
- DOI https://doi.org/10.37191/Mapsci-2582-4333-2(2)-031
- Views 51
- Downloads 0
Evaluation of Nutritional Status among Adult Hemophilia patients enrolled in European Gaza hospital in Gaza strip, Palestine
Overview: Hemophilia is a genetic bleeding disorder caused by a deficiency of clotting factor and classified to Hemophilia A and B. Nutritional status is very important and proper nutrition among hemophilia patients is h...
Amplification of ABCG2 Transporter Gene Exon 8 and 14 of Diabetic Patients
Diabetes is a serious illness affecting over 425 million people worldwide. Diabetes develops as a result of the failure of the pancreatic β-cells to produce the hormone insulin in the amount required to meet the body's n...
Presence of Proteins in 17% EDTA after Contact with the Bovine Dentine
EDTA 17% is a solution frequently used in endodontics for the extraction of the mineralized remains of dentine from the root canals. Its chelating action could affect the dentine making it susceptible to insults. The obj...
Editor Note on SALBUTAMOL: Historical Reality: A Saving Life in the Asthmatic; and Doping for the Sportsman
Asthma of the Greek "asthma" means little or no breath. The beliefs of the ancient times cite as the causes of this disease the cooling and humidity of the lung, in the Middle Ages, the first treatise on asthma offers va...
Crossroad of Molecular Networks and Disease Treatment
Various molecular networks including both canonical and non-canonical pathways are activated in cancer. It has some rationales to target the molecular network pathways to treat cancer, considering that the pathway regula...