Clinical trial Investigator Responsibilities (2nd article) Protecting the Rights, Safety, and Welfare of Study Subjects
Investigators are responsible for protecting the rights, safety, and welfare of subjects under their care during a clinical trial of a drug (21 CFR 312.60 and 812.100). This responsibility should include:
Providing reasonable medical care for study subjects for medical problems arising during participation in the trial that are, or could be, related to the study intervention
Providing reasonable access to needed medical care, either by the investigator or by another identified, qualified individual (e.g., when the investigator is unavailable, when specialized care is needed)
Adhering to the protocol so that study subjects are not exposed to unreasonable risks
The investigator should inform the subject's primary physician about the subject's participation in the trial if the subject has a primary physician and the subject agrees to the primary physician being informed.
1. Reasonable Medical Care Necessitated by Participation in a Clinical Trial
During a subject's participation in a trial, the investigator (or designated subinvestigator) should ensure that reasonable medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial participation. If the investigator does not possess the expertise necessary to provide the type of medical care needed by a subject, the investigator should make sure that the subject is able to obtain the necessary care from a qualified practitioner. For example, if the study involves placement of a carotid stent by an interventional neuroradiologist and the subject suffers a cerebral stroke, the neuroradiologist should assess the clinical status of the subject and arrange for further care of the subject by a neurologist. Subjects should receive appropriate medical evaluation and treatment until resolution of any emergent condition related to the study intervention that develops during or after the course of their participation in a study, even if the follow-up period extends beyond the end of the study at the investigative site.
The investigator should also inform a subject when medical care is needed for conditions or illnesses unrelated to the study intervention or the disease or condition under study when such condition or illness is readily apparent or identified through the screening procedures and eligibility criteria for the study. For example, if the investigator determines that the subject has had an exacerbation of an existing condition unrelated to the investigational product or the disease or condition under study, the investigator should inform the subject. The subject should also be advised to seek appropriate care from the physician who was treating the illness prior to the study, if there is one, or assist the subject in obtaining needed medical care.
2.Reasonable Access to Medical Care
Investigators should be available to subjects during the conduct of the trial for medical care related to participation in the study. Availability is particularly important when subjects are receiving a drug that has significant toxicity or abuse potential. For example, if a study drug has potentially fatal toxicity, the investigator should be readily available by phone or other electronic communication 24 hours a day and in reasonably close proximity to study subjects (e.g., not in another state or on prolonged travel). Study subjects should be clearly educated on the possible need for such contact and on precisely how to obtain it, generally by providing pertinent phone numbers, e-mail addresses, and other contact information, in writing. Prior to undertaking the conduct of a study, prospective investigators should consider whether they can be available to the extent needed given the nature of the trial.
During any period of unavailability, the investigator should delegate responsibility for medical care of study subjects to a specific qualified physician who will be readily available to subjects during that time (in the manner a physician would delegate responsibility for care in clinical practice). If the investigator is a non-physician, the investigator should make adequate provision for any necessary medical care that the investigator is not qualified to provide.
3. Protocol Violations that Present Unreasonable Risks
There are occasions when a failure to comply with the protocol may be considered a failure to protect the rights, safety, and welfare of subjects because the non-compliance exposes subjects to unreasonable risks. For example, failure to adhere to inclusion/exclusion criteria that are specifically intended to exclude subjects for whom the study drug or device poses unreasonable risks (e.g., enrolling a subject with decreased renal function in a trial in which decreased function is exclusionary because the drug may be nephrotoxic) may be considered failure to protect the rights, safety, and welfare of the enrolled subject. Similarly, failure to perform safety assessments intended to detect drug toxicity within protocol-specified time frames (e.g., CBC for an oncology therapy that causes neutropenia) may be considered failure to protect the rights, safety, and welfare of the enrolled subject. Investigators should seek to minimize such risks by adhering closely to the study protocol.
CLINICAL TRIAL INVESTIGATOR RESPONSIBILITIES PART ONE
Requiremets US FDA Inspections of Clinical Investigators of Clinical Trials
Also see US FDA requirements of reporting of adverse events in a clinical trial US FDA has recently updated its requirement.
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Investigators are responsible for protecting the rights, safety, and welfare of subjects under their care during a clinical trial of a drug (21 CFR 312.60 and 812.100). This responsibility should include:
Providing reasonable medical care for study subjects for medical problems arising during participation in the trial that are, or could be, related to the study intervention
Providing reasonable access to needed medical care, either by the investigator or by another identified, qualified individual (e.g., when the investigator is unavailable, when specialized care is needed)
Adhering to the protocol so that study subjects are not exposed to unreasonable risks
The investigator should inform the subject's primary physician about the subject's participation in the trial if the subject has a primary physician and the subject agrees to the primary physician being informed.
1. Reasonable Medical Care Necessitated by Participation in a Clinical Trial
During a subject's participation in a trial, the investigator (or designated subinvestigator) should ensure that reasonable medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial participation. If the investigator does not possess the expertise necessary to provide the type of medical care needed by a subject, the investigator should make sure that the subject is able to obtain the necessary care from a qualified practitioner. For example, if the study involves placement of a carotid stent by an interventional neuroradiologist and the subject suffers a cerebral stroke, the neuroradiologist should assess the clinical status of the subject and arrange for further care of the subject by a neurologist. Subjects should receive appropriate medical evaluation and treatment until resolution of any emergent condition related to the study intervention that develops during or after the course of their participation in a study, even if the follow-up period extends beyond the end of the study at the investigative site.
The investigator should also inform a subject when medical care is needed for conditions or illnesses unrelated to the study intervention or the disease or condition under study when such condition or illness is readily apparent or identified through the screening procedures and eligibility criteria for the study. For example, if the investigator determines that the subject has had an exacerbation of an existing condition unrelated to the investigational product or the disease or condition under study, the investigator should inform the subject. The subject should also be advised to seek appropriate care from the physician who was treating the illness prior to the study, if there is one, or assist the subject in obtaining needed medical care.
2.Reasonable Access to Medical Care
Investigators should be available to subjects during the conduct of the trial for medical care related to participation in the study. Availability is particularly important when subjects are receiving a drug that has significant toxicity or abuse potential. For example, if a study drug has potentially fatal toxicity, the investigator should be readily available by phone or other electronic communication 24 hours a day and in reasonably close proximity to study subjects (e.g., not in another state or on prolonged travel). Study subjects should be clearly educated on the possible need for such contact and on precisely how to obtain it, generally by providing pertinent phone numbers, e-mail addresses, and other contact information, in writing. Prior to undertaking the conduct of a study, prospective investigators should consider whether they can be available to the extent needed given the nature of the trial.
During any period of unavailability, the investigator should delegate responsibility for medical care of study subjects to a specific qualified physician who will be readily available to subjects during that time (in the manner a physician would delegate responsibility for care in clinical practice). If the investigator is a non-physician, the investigator should make adequate provision for any necessary medical care that the investigator is not qualified to provide.
3. Protocol Violations that Present Unreasonable Risks
There are occasions when a failure to comply with the protocol may be considered a failure to protect the rights, safety, and welfare of subjects because the non-compliance exposes subjects to unreasonable risks. For example, failure to adhere to inclusion/exclusion criteria that are specifically intended to exclude subjects for whom the study drug or device poses unreasonable risks (e.g., enrolling a subject with decreased renal function in a trial in which decreased function is exclusionary because the drug may be nephrotoxic) may be considered failure to protect the rights, safety, and welfare of the enrolled subject. Similarly, failure to perform safety assessments intended to detect drug toxicity within protocol-specified time frames (e.g., CBC for an oncology therapy that causes neutropenia) may be considered failure to protect the rights, safety, and welfare of the enrolled subject. Investigators should seek to minimize such risks by adhering closely to the study protocol.
CLINICAL TRIAL INVESTIGATOR RESPONSIBILITIES PART ONE
Requiremets US FDA Inspections of Clinical Investigators of Clinical Trials
Also see US FDA requirements of reporting of adverse events in a clinical trial US FDA has recently updated its requirement.
=====================================================================================================
Do you know now this website has become a most popular and most referred website in pharmaceutical industry and pharmaceutical companies and pharmaceutical manufacturers from all over the world ,for almost all topics related to Pharmaceutical Manufacturing , Pharmaceutical Regulatory Affairs and Good Manufacturing Practice for Pharmaceutical Manufacturing (c GMP guidelines ) and latest news and new drugs developments.
=====================================================================================================
You may also like following articles
What is a Site Master file of a pharmaceutical company
What is Generic Drug
What is Referance Listed Drug ? ( RLD )
What is Pharmaceutical Equivalents
What is Pharmaceutical Alternatives
What is Therapeutic Equivalents
Why a drug is bound to protein, What is protein binding? What is drug absorption , distribution ?
Do Physical properties contribute to drug activity.
What is drug receptor , How a drug resistance occurs
Mechanism of drug resistance
What is drug interaction
Drug interaction, and its examples
What is first pass metabolism of a drug
What is What is 510(k) Clearances ?
What is 510(k) Clearances,
Premarket Notification for medical devices - PMN or 510(k)
What is a drug interaction
Examples of drug interactions
Antibiotic Definition and classification
Antibiotic resitance and Antibiotic resistance mechanism
Antioxidants food suppliments
Vitamin D Details on FDA cautions on accurate dosage of Vitamin D
What is an antibody? what is monoclonal and polyclonal antibodies?
Terminologies In vaccine Production
Multi stage testing of Virus vaccine production
Testing of vaccines at different stages of production
TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION
Enzyme linked immunosorbent assay ELISA
Raido Immuno assay
http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html
Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.
http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html
Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in
pharmaceutical industry
Pharmaceutical Validation
Types of validations in pharmaceutical manufacturing
Requirements of documents for validation of sterilisation process
How to investigate OOS out of specification results
Determination of Phenol coefficient of a disinfectant
Sterility testing
Cleen Room Classification
Time limitations in sterile pharmaceuticals processing
Aspects of validation of manufacturing process in sterile pharmaceuticals
Clinical Trials
Requiremets US FDA Inspections of Clinical Investigators of Clinical Trials
PROCEDURE OF AN INSPECTIONS OF CLINICAL TRIAL INVESTIGATOR BY US FDAHOW ARE CLINICAL INVESTIGATOR INSPECTIONS CONDUCTED?
US FDA INSPECTION OF CLINICAL INVESTIGATORS OUT OF UNITED STATES OF AMERICA
REPORTS AFTER AN INSPECTION OF A INVESTIGAOTR OF CLINICAL TRIALS
Controlling Pyrogens in injectable dosage forms
Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation
New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA
Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA
How to make Investigational New Drug (IND) Application to US FDA
Drug applications submission to us fda Over the counter Drugs OTC drugs
BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Electronic record in pharmaceutical manufacturing industry
Good manufacturing practice in pharmaceutical industry
Pharmaceutical industry pharmaceutical companies and FDA latest updates
Here is an interesting article on world wide pharmaceutical industry and making a carrier in one of pharmaceutical companies article on Pharmaceutical Industry pharmaceutical industry
Find a Job in Pharmaceutical Company -->JOBS IN PHARMA INDUSTRY<---
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies
Here are some interesting articles on Quality assurance systems for pharmaceutical company
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Quality by designe concept in pharmaceutical industryan explanation
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