Who is responsible for obtaining informed consent in clinical trials?

2. Informed consent in medical research: The principal investigator’s team. The human subjects of medical studies must also provide informed consent. When those studies are part of the FDA approval process for a new drug or medical device, a lot of organizations get involved.

Who acts as the main line of communication between the sponsor and the investigator?

The monitor(s) in accordance with the sponsor’s requirements should ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site: Acting as the main line of communication between the sponsor and the investigator.

Who is responsible for the conduct of the clinical trial at a trial site?

the investigator
A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

Who is responsible for clinical trial?

Who Conducts Clinical Studies? Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals.

How can informed consent of the participants be obtained?

Informed consent is documented by means of a written, signed and dated informed consent form. The informed consent form must be written in language easily understood by the subjects, it must minimise the possibility of coercion or undue influence, and the subject must be given sufficient time to consider participation.

Who is responsible for getting consent?

Health Practitioner
The responsibility for obtaining informed consent rests with the Health Practitioner who has the responsibility and accountability for the specific treatment or procedure being provided to a patient, assuming he/she is authorized by AHS to deliver the treatment/procedure within his/her scope of practice.

Who are stakeholders in a clinical trial?

The stakeholders of clinical research industry are subjects, sponsor, investigator and team, government agencies, Regulatory authorities, monitor, Institutional review board, Contract research organization, Independent ethics committee, Academic institutions, public and private sectors whose contribution significantly …

Who informs the investigator about record retention?

the sponsor
As the sponsor is knowledgeable about the status of its investigational product, it is the responsibility of the sponsor to inform the investigator/institution as to when these documents no longer need to be retained.

Who regulates clinical trials in India?

The Drugs Controller General of India (DCGI) is an official of the CDSCO who is the final regulatory authority for the approval of clinical trials in the country.

Who are the participants of GCP?

The responsibility for GCP is shared by all of the parties involved, including sponsors, investigators and site staff, contract research organizations (CROs), ethics committees, regulatory authorities and research subjects.

Why should information provided by participants be made confidential?

Maintaining privacy and confidentiality helps to protect participants from potential harms including psychological harm such as embarrassment or distress; social harms such as loss of employment or damage to one’s financial standing; and criminal or civil liability.

How can confidentiality of the participants be protected?

Breach of confidentiality is a potential risk of participating in research. To protect participants’ confidentiality, you should encrypt computer-based files, store documents (i.e., signed consent forms) in a locked file cabinet and remove personal identifiers from study documents as soon as possible.

When should a subject be informed about a clinical trial?

The subject or the subject’s legally acceptable representative should be informed about the trial as soon as possible and consent to continue and other consent as appropriate (see 4.8.10) should be requested. Section 4. INVESTIGATOR, 4.8 Informed Consent of Trial Subjects, GUIDELINE FOR GOOD CLINICAL PRACTICE ICH E6 (R2)

Do you need consent to participate in a clinical trial?

It is federal law to have written informed consent before any person can take part in any clinical trial. Signing an informed consent form is a written agreement that you or your representative fully understand the parameters of a given trial and are willing to participate in the study.

What information should be included in a clinical trial protocol?

Include the following section only if the protocol is for a clinical trial: Information on the Trial Drug [Name of Drug] 1) give the phase of the trial and explain what that means. Explain to the participant why you are comparing or testing the drugs.

How is information provided to potential participants?

This information is provided to potential participants through the informed consent process. Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work. A central part of the informed consent process is the informed consent document.