FREE ACRP Clinical Study Protocols Question and Answers
Profile of the investigational product that includes
Pre‐clinical and clinical trial experience to date
Method of action
ADME properties
Safety profile - what adverse events are expected?
Dosage
Contraindications
PI must be familiar with content
The Investigator's Brochure is a comprehensive document prepared by the sponsor of a clinical trial. It provides detailed information about the investigational product being studied in the trial. The purpose of the Investigator's Brochure is to ensure that all investigators involved in the trial have the necessary information to conduct the study safely and effectively.
Promote & protect public health by helping safe & effective drugs reach market
• Monitor for continued safety after approved
• Enforce regulations regarding:
- Testing of drugs & medical devices in humans
- Manufacturing process of drugs & devices
- Sanitation of foods
- Use of pesticides
- Veterinary medicine C
Understanding the FDA's mission and regulatory role is essential for stakeholders in the pharmaceutical, medical device, food, and cosmetics industries to comply with standards and ensure the safety and efficacy of products reaching consumers.
Sponsor can transfer all or some
responsibilities of a trial to a CRO
Must be in writing
Ultimate responsibility for quality and
integrity of the trial data remains with
sponsor
CRO must comply with "sponsor" regulatory
obligations for responsibilities transferred
This refers to the process where a sponsor (the entity funding or initiating a clinical trial) can delegate some or all of the responsibilities associated with the trial to a Contract Research Organization (CRO).
The transfer of these responsibilities must be documented in writing, usually through a formal agreement or contract between the sponsor and the CRO.
Despite delegating certain tasks to the CRO, the ultimate responsibility for ensuring the quality and integrity of the trial data remains with the sponsor.
The CRO is also obligated to comply with the sponsor's regulatory requirements and standards for the responsibilities that have been transferred.
A clinical trial being conducted to confirm the safety and tolerability of a new anti-emetic IP would be considered what phase of clinical study?
Phase I trials are critical for establishing the initial safety profile and pharmacokinetic properties of a new investigational product before proceeding to later phases of clinical development.
Track revenues earned exactly
- Create spreadsheet of study patient activity
• Provides view of study progress
• Include amount earned, amount invoiced, amount received, & summary
• Things that can affect payment:
- Completed case report forms
- Amount of data retrieved by monitor
Managing accounts receivable is essential for maintaining financial stability and ensuring that all revenues and payments related to clinical trials are accurately tracked and managed.
• FDA Investigations Operational Manual for conducting inspections
• When inspector arrives:
- Verify their credentials
- Record inspector's badge #
- Obtain a copy of 482
• Inspector's Assignment
These steps and considerations are crucial for facilities subject to FDA inspections to ensure compliance with regulatory standards and facilitate a smooth and efficient inspection process. Understanding and adhering to FDA inspection procedures contribute to maintaining quality and regulatory compliance within the industry.
Should be chosen based on:
- Clinical expertise
- Availability
- Willingness to participate in research
• Reimbursement based on usual fee + 10%
• May be able to get at reduced rate
- i.e. volume discount
• Only enter into budget once rate agreed upon by both parties
- Written agreement of rates/service fees
- Do not estimate!!
Understanding the role of CRAs and budgeting considerations is essential for effective management and coordination of clinical research activities.
Ensuring QA of inputs ultimately ensures QA of outputs... the data
• Audits should occur to ensure integrity of data
• Where does data come from?
• When should final QA inspection occur?
Maintaining QA of data inputs is essential for generating reliable and valid outcomes in clinical research studies.
Standard Operating Procedures (SOPs)
SOPs serve as guidance documents for the conduct of clinical research, outlining the standards and procedures that govern site operations. They are typically required by regulatory bodies such as the FDA and must be followed precisely to ensure compliance and consistency in research practices.
Issues that may be addressed in SOPs include recruitment procedures, scheduling protocols, ongoing participant management, management of adverse events, adherence to inclusion/exclusion criteria, handling of medical opinions or advice, and documentation requirements.
Maintaining and adhering to SOPs is crucial for ensuring the integrity, quality, and regulatory compliance of clinical research activities.
• "Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject"
• "Is purported or represented to be for use supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject"
• "Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject"
• "Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject"
In clinical trials involving Significant Risk Devices, sponsors must comply with specific regulations and obtain appropriate approvals before initiating the investigation. These devices are subject to stringent oversight to ensure the protection and safety of research subjects.
• Education, credentials, training, and experience
- Background in clinical area
- Operational, regulatory, ethical training in conduct of clinical trials
- Certifications
• Association of Clinical Research Professionals (ACRP)
- 2 years of experience & passing exam
• Study‐specific training
- Investigator meeting
- Initiation visit
QA of study personnel involves assessing the performance, competence, and compliance of individuals involved in conducting the clinical trial.
This includes evaluating adherence to protocols, ethical standards, and regulatory requirements to ensure the quality and integrity of the research.