Which of the following does 21 CFR Part 312 deal with?

Which of the following does 21 CFR Part 312 deal with?

Content: This part contains procedures governing the use of investigational new products including the submission to, and review by, the FDA.

What is a sponsor investigator?

Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual.

What are the sponsor’s responsibilities in a trial that is federally funded and regulated by the FDA?

Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols …

Who is investigator in clinical trial?

Who is an Investigator? An individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is dispensed to a subject.) In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team.

What are the 13 principles of ICH GCP?

• Ethics.
• Trial risk vs trial benefit.
• Information on the Medicinal Product.
• Compliance with the study protocol.
• Medical decisions.
• Informed consent.
• Confidentiality.
• Good Manufacturing Practice.

What are GCP guidelines?

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects.

What are study protocols?

A clinical study protocol is a document that describes the study objectives, design, methods, assessment types, collection schedules, and statistical considerations for analyzing the data. The protocol also outlines steps for protecting subjects and obtaining quality data.

What should a protocol include?

The protocol should outline the rationale for the study, its objective, the methodology used and how the data will be managed and analysed. It should highlight how ethical issues have been considered, and, where appropriate, how gender issues are being addressed.

How do you write a good lab protocol?

Structure of an Effective Lab Protocol

1. Use a Template Protocol.
2. Effective Lab Protocols Include All Reagents and Equipment Required.
3. Effective Lab Protocols Cover Safety Too!
4. Detailed Protocols Are Effective Lab Protocols.
5. Break up Walls of Text with Numbered Points.
6. Make It Personal with Tips and Tricks.

What are lab protocols?

A lab protocol is a set of instructions that enable scientists, and science students, to carry out previously-conducted experiments, in the comfort of their own laboratories. Typically, lab protocols consist of the experiment procedures, safety protocols, as well as the required equipment to carry out the experiment.

What is the most important lab safety rule?

Dress for the lab. This is a safety rule because your clothing is one of your best forms of protection against an accident. For any science lab, wear covered shoes, long pants, and keep your hair up so it can’t fall into your experiment or a flame. Make sure you wear protective gear, as needed.

What are pharmaceutical protocols?

A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report and approval.

What is the incident in pharma?

Laboratory Incident: Any unintentional/ unexpected event that occurs during analysis which is discovered during analysis or after analysis which adversely affects the data quality or representativeness and affects the result.

How do you create a process validation protocol?

Quality Assurance Department

1. Prepare, review, approve and execution of protocol.
2. Provide training to concerned personnel.
3. Withdraw the samples as per the sampling plan.
4. Monitor validation activities.
5. Review the validation data, and.
6. Provide the final conclusion of the Process qualification in the reports.