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A study of practical parameters and their relative importance as perceived by various stakeholders in clinical trials.

Pant R, Joshi Y - J Young Pharm (2011)

Bottom Line: There are literally hundreds of CROs worldwide employing a workforce of nearly 100,000 professionals.The survey was conducted in Bangalore and New Delhi.There were 15 Sponsors/ CROs, 27 Investigators /Monitors and 38 Ethics committee members involved in the study.

View Article: PubMed Central - PubMed

Affiliation: Himalayan Institute of Pharmacy & Research, Atak Farm, Rajawala, via Prem Nagar, Dehradun (Uttarakhand), India.

ABSTRACT
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.

No MeSH data available.


Parameters of study design to conduct GCP clinical trials
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Related In: Results  -  Collection

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Figure 0002: Parameters of study design to conduct GCP clinical trials

Mentions: IV. Parameters of study design to conduct GCP clinical trial according to the Investigators’ opinion [Figure 2]Figure 2


A study of practical parameters and their relative importance as perceived by various stakeholders in clinical trials.

Pant R, Joshi Y - J Young Pharm (2011)

Parameters of study design to conduct GCP clinical trials
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3094562&req=5

Figure 0002: Parameters of study design to conduct GCP clinical trials
Mentions: IV. Parameters of study design to conduct GCP clinical trial according to the Investigators’ opinion [Figure 2]Figure 2

Bottom Line: There are literally hundreds of CROs worldwide employing a workforce of nearly 100,000 professionals.The survey was conducted in Bangalore and New Delhi.There were 15 Sponsors/ CROs, 27 Investigators /Monitors and 38 Ethics committee members involved in the study.

View Article: PubMed Central - PubMed

Affiliation: Himalayan Institute of Pharmacy & Research, Atak Farm, Rajawala, via Prem Nagar, Dehradun (Uttarakhand), India.

ABSTRACT
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.

No MeSH data available.