Pant R, Joshi Y
Himalayan Institute of Pharmacy & Research, Atak Farm, Rajawala, via Prem Nagar, Dehradun (Uttarakhand), India.
J Young Pharm. 2011 Jan;3(1):60-4. doi: 10.4103/0975-1483.76421.
A contract research organization (CRO) is a company which conducts a Good Clinical Practice (GCP) in clinical trial. There are literally hundreds of CROs worldwide employing a workforce of nearly 100,000 professionals. The project proposes the study of practical parameters and their relative importance as perceived by the various stakeholders in clinical trials. The survey was conducted in Bangalore and New Delhi. Primary market data was obtained by primary market research which included 80 clinical trial stakeholders by having a preliminary communication with them, followed by administering a questionnaire along with prior permission. There were 15 Sponsors/ CROs, 27 Investigators /Monitors and 38 Ethics committee members involved in the study. It was shown from the study that a clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of the subjects under the investigator's care; and for the control of drugs under investigation. It was also shown from the study that the sponsors of a clinical trial carry the ultimate responsibility for the initiation, management and financing of the clinical trial. The study has identified a specific training need at the level of the individual stakeholder to perform a particular job function and to identify the actual practical parameters in the Indian context important for the conduction of clinical trials (GCP) with respect to the different stakeholders, to determine the relative importance of these parameters as perceived by various stakeholders involved in clinical trials, and to identify the relative contributions of different stakeholders to the success/ satisfactory conduct of a clinical trial.
合同研究组织（CRO）是一家在临床试验中开展良好临床实践（GCP）的公司。全球实际上有数百个CRO，雇佣了近10万名专业人员。该项目提议研究临床试验中各利益相关者所感知的实际参数及其相对重要性。调查在班加罗尔和新德里进行。通过初步市场研究获得一手市场数据，包括与80名临床试验利益相关者进行初步沟通，然后在获得事先许可的情况下发放问卷。参与该研究的有15名申办者/CRO、27名研究者/监查员和38名伦理委员会成员。研究表明，参与临床试验的临床研究者有责任确保按照签署的研究者声明、研究计划和适用法规进行研究；保护研究者所负责受试者的权利、安全和福利；以及控制研究中的药物。研究还表明，临床试验的申办者对临床试验的启动、管理和资金承担最终责任。该研究确定了个体利益相关者层面的特定培训需求，以便履行特定工作职能，并确定在印度背景下对开展临床试验（GCP）而言重要的实际参数，这些参数对于不同利益相关者而言，确定各利益相关者所感知的这些参数的相对重要性，以及确定不同利益相关者对临床试验成功/令人满意开展的相对贡献。
