Clinical Investigator Responsibilities

Baer, Allison R.; Devine, Susan; Beardmore, Chris David; Catalano, Robert B.

doi:10.1200/jop.2010.000216

Cited by 22 publications

(24 citation statements)

References 1 publication

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“…Proof of obtaining informed consent is documented using a written, signed and dated informed consent form (ICF) [2]. Informed consent is a procedure through which subjects, after having received the entire content and procedures of the clinical trial, can voluntarily provide willingness for participation; it is the investigator's responsibility to ensure that the consent process is conducted appropriately [2,3]. Although the GCP guidelines provide a list of topics which should be presented both in the informed consent discussion and in the ICF, they do not give any advice on how to provide this information.…”

Section: Introductionmentioning

confidence: 99%

Informed consent procedure in a double blind randomized anthelminthic trial on Pemba Island, Tanzania: do pamphlet and information session increase caregivers knowledge?

et al. 2020

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Background: In clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant's true comprehension. New effective methods of conveying consent information should be tested. In this study we compared the effect of different methods on the knowledge of caregivers of participants of a clinical trial on Pemba Island, Tanzania. Methods: A total of 254 caregivers were assigned to receive (i) a pamphlet (n = 63), (ii) an oral information session (n = 62) or (iii) a pamphlet and an oral information session (n = 64) about the clinical trial procedures, their rights, benefits and potential risks. Their post-intervention knowledge was assessed using a questionnaire. One group of caregivers had not received any information when they were interviewed (n = 65). Results: In contrast to the pamphlet, attending an information session significantly increased caregivers' knowledge for some of the questions. Most of these questions were either related to the parasite (hookworm) or to the trial design (study procedures). Conclusions: In conclusion, within our trial on Pemba Island, a pamphlet was found to not be a good form of conveying clinical trial information while an oral information session improved knowledge. Not all caregivers attending an information session responded correctly to all questions; therefore, better forms of communicating information need to be found to achieve a truly informed consent.

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Section: Introductionmentioning

confidence: 99%

Informed consent procedure in a double blind randomized anthelminthic trial on Pemba Island, Tanzania: do pamphlet and information session increase caregivers knowledge?

et al. 2020

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“…It is essential for all individuals involved in clinical research to have knowledge and understanding of research-related laws and regulations to ensure GCP. 24–26 …”

Section: The Research Teammentioning

confidence: 99%

“…Table 4 outlines the general responsibilities of the PI, study coordinator, and research participant. 24–29 It is important to note that U.S. regulations only outline the role of the Investigator, not other research team members.…”

Section: The Research Teammentioning

confidence: 99%

Clinical Trials and the Role of the Oncology Clinical Trials Nurse

Ness

Royce

2017

Nursing Clinics of North America

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Clinical trials will continue to be paramount to improving human health. New trial designs and informed consent issues are emerging as a result of genomic profiling and the development of molecularly targeted agents. Many groups and individuals are responsible for ensuring the protection of research participants and the quality of the data produced. The specialty role of the Clinical Trials Nurse (CTN) is critical to the implementation of clinical trials. Oncology CTNs have established competencies that can help guide their practice; yet, not all oncology CTNs are supervised by a nurse. Using the process of engagement, one organization has successfully restructured the oncology CTNs under a nurse-supervised model.

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“…The PI is responsible for the overall administrative, fiscal, scientific, and ethical aspects of a research project and supervises research staff and students. Besides, the PI adheres to the institutional policies, and the institutional review board (IRB) policies and procedures regarding the safety and protection of human subjects, and good clinical practice guidelines [4,5]. In Saudi Arabia, there is also a need for assuring compliance with the National Committee of Bioethics (NCBE) regulations [6].…”

Section: Introductionmentioning

confidence: 99%

Eligibility of Medical Students to Serve as Principal Investigator: An Evidence-based Approach

Rajab

Gazal

Al-Kawi

et al. 2020

Cureus

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Clinical Investigator Responsibilities

Abstract: When conducting a clinical trial, it is important that clinical investigators successfully meet all research expectations, including regulatory requirements and the Guidelines for Good Clinical Practice.

Cited by 22 publications

References 1 publication

Informed consent procedure in a double blind randomized anthelminthic trial on Pemba Island, Tanzania: do pamphlet and information session increase caregivers knowledge?

Informed consent procedure in a double blind randomized anthelminthic trial on Pemba Island, Tanzania: do pamphlet and information session increase caregivers knowledge?

Clinical Trials and the Role of the Oncology Clinical Trials Nurse

Eligibility of Medical Students to Serve as Principal Investigator: An Evidence-based Approach

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