Regulatory requirements investigator

An inveshgator must be qualified by educahon, training, and experience to assume responsibility for the proper conduct of a clinical trial and should meet all qualifications specified by the applicable regulatory requirements. Investigators must agree to abide by the decisions of their selected IRB and should comply with all governing rules and regulations. 

Name and description of the investigational product(s). A summary of findings from non-clinical sfudies and from clinioal trials that is relevant to the trial. Summary of the known and potential risks and benefits, if any, to human subjects. Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s). A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s). Description of the population to be studied. References to literature and data that are relevant to the trial, and that provide background for the trial... 

Research investigators should be aware of the ethical, legal, and regulatory requirements for research on human subjects in their own countries as well as applicable international requirements. No national ethical, legal, or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in this Declaration. 

Determining how investigation results will be routed and to whom (including regulatory-required routing). 

This section lists sources used to develop the incident investigation management system corporate guidance, regulatory requirements, and other reference materials such as this hook. 

The use of an alert card is not a specific regulatory requirement. However, in many clinical trials, it is appropriate that an alert card is given to subjects, particularly if they are outpatients. In an emergency, the alert card will identify that the subject is in a clinical trial and provide information on the nature of the clinical trial and whom to contact for information. The alert card should contain the sponsor s name and address (if appropriate), investigator s name, address and telephone number, with a 24-h contact number (the contact should have knowledge of the study and not just be an on-calT physician), the protocol number, the indication (perhaps modified to be more acceptable to the subject) and the subject s name and address and identification number. 

Research investigators should be aware of the ethical, legal and regulatory requirements for research on human subjects in their own countries as well as applicable international... 

Investigations. Investigations are a regulatory requirement to explain events and deviations that took place during the processing of the product. 

Select qualified investigators and obtain from them a commitment to conduct the investigation study in accordance with the protocol and all regulatory requirements. 

Adverse event documentation and reporting The investigator and staff must understand the regulatory requirement for reporting adverse drug... 

There are no additional or reduced regulatory requirements for closing sites. Computer systems should be maintained in a validated state of compliance up until the very last day of their operational life. GxP records must be archived and stored for the required retention periods. Archived records should be readily retrievable to support critical quality operations like recall, customer complaints, and batch investigation. Computer systems should then be decommissioned, as discussed later in this chapter. Some computer systems may be disassembled and sent for installation at other sites as part of a program of drug product transfers. 

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