QbD Clinical
1. Role of various clinical partners: parties involved
when conducting a clinical trial
Sponsor
= An individual, company, institution, or organization which takes responsibility
for the initiation, management, and/or financing of a clinical trial.
• Clinical investigation planning and conduct
● Selection and training of clinical personnel
● Preparation of documents and materials
● Monitoring
● Supplying and Handling Investigational Product(s)
● Conduct of clinical investigation
● Safety evaluation and reporting
● Clinical investigation close-out
• Clinical Quality Management: implement a system to manage quality
throughout all stages of the trial
• Communication with regulatory authorities
Outsourcing of duties and functions
• The sponsor may transfer any or all the duties and functions related to
the clinical investigation, to an external organization or CRO
• BUT the ultimate responsibility for the quality and integrity of the
clinical investigation conduct shall reside with the sponsor.
• Any trial-related duty and function that is transferred to a CRO should be
specified in writing (=contractual agreement)
• The sponsor shall ensure oversight of any clinical investigation-related
duties and functions carried out on its behalf.
CRO = contract research organization
Person or organization contracted by the Sponsor to perform one or more of the
Sponsor's clinical investigation-related duties and functions
• A company that provides clinical trial services for the Sponsor
• CROs are hired by Sponsors:
• Sponsor might not have the personnel or expertise
• CROs have the knowledge, capabilities, processes and procedures
that are needed to develop and run a successful clinical trial
• CROs improve trial efficiency and decreased timelines and cost
• Main contact between the sponsor and other stakeholders
throughout the trial
Investigation site
= institution or site where the clinical investigation is carried out
1
, • Monocentric trial: clinical investigation conducted at 1 site
• Multicentre trials: clinical investigation conducted according to a single
protocol at 2 or more investigation sites (in 1 or more countries)
Who is involved in the clinical trial at the investigation
site?
Principle 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.
See also Sub-investigator.
• Mostly a physician (or dentist) (but this is not required)
• Implement, oversee the management of the conduct of the clinical
investigation
• Ensure data integrity and the rights, safety, and well-being of the subjects
• May delegate tasks to qualified members of the investigation site team but
retains responsibility & must have a list of qualified persons to whom
duties have been delegated
• PI has the final accountability, oversight
• Compliance with the protocol, investigational product, responsible
for the informed consent, safety reporting, keep records and
reports
Adequate resources: for recruiting subjects, qualified staff, adequate facilities
Sub investigator
• Member of the site team, designated and supervised by the Principal
Investigator
• Perform clinical investigation-related procedures or make important clinical
investigation-related and medical treatment decisions
• In general, in EU the term investigator is used for a MD (or dentist) and not
a nurse
2
, Clinical research nurse
-> term not defined -> sometimes called clinical trial nurse, clinical study
nurse
-> involved in data collection and data transcription
-> responsibilities may be difficult depending on the legal definition of
responsibilities of a nurse within a country
Data manager
-> not defined
-> not the data manager as from a sponsor
-> Sometimes a nurse, but can also be an admin support responsible for the
various entries in eCRF (data transcription), interaction with sponsor,
documentation.
Pharmacist
-> Not defined as part of clinical trial regulations or ethical principles
-> Often responsible for the receipt of the investigational product (and
sometimes device)
-> Depending on the organization on site, may be responsible for stock, storage,
drug preparation, distribution, return, accountability …
Other: specialized departments may be involved depending on the trial design
2. Trial-related roles and functions
Which departments/roles are involved in the clinical trial at the
CRO/sponsor?
2.1. Clinic
al operations and project management
Because of the various parties involved in clinical research and all regulations
and guidelines to follow, and because clinical research has to be done within the
3
1. Role of various clinical partners: parties involved
when conducting a clinical trial
Sponsor
= An individual, company, institution, or organization which takes responsibility
for the initiation, management, and/or financing of a clinical trial.
• Clinical investigation planning and conduct
● Selection and training of clinical personnel
● Preparation of documents and materials
● Monitoring
● Supplying and Handling Investigational Product(s)
● Conduct of clinical investigation
● Safety evaluation and reporting
● Clinical investigation close-out
• Clinical Quality Management: implement a system to manage quality
throughout all stages of the trial
• Communication with regulatory authorities
Outsourcing of duties and functions
• The sponsor may transfer any or all the duties and functions related to
the clinical investigation, to an external organization or CRO
• BUT the ultimate responsibility for the quality and integrity of the
clinical investigation conduct shall reside with the sponsor.
• Any trial-related duty and function that is transferred to a CRO should be
specified in writing (=contractual agreement)
• The sponsor shall ensure oversight of any clinical investigation-related
duties and functions carried out on its behalf.
CRO = contract research organization
Person or organization contracted by the Sponsor to perform one or more of the
Sponsor's clinical investigation-related duties and functions
• A company that provides clinical trial services for the Sponsor
• CROs are hired by Sponsors:
• Sponsor might not have the personnel or expertise
• CROs have the knowledge, capabilities, processes and procedures
that are needed to develop and run a successful clinical trial
• CROs improve trial efficiency and decreased timelines and cost
• Main contact between the sponsor and other stakeholders
throughout the trial
Investigation site
= institution or site where the clinical investigation is carried out
1
, • Monocentric trial: clinical investigation conducted at 1 site
• Multicentre trials: clinical investigation conducted according to a single
protocol at 2 or more investigation sites (in 1 or more countries)
Who is involved in the clinical trial at the investigation
site?
Principle 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.
See also Sub-investigator.
• Mostly a physician (or dentist) (but this is not required)
• Implement, oversee the management of the conduct of the clinical
investigation
• Ensure data integrity and the rights, safety, and well-being of the subjects
• May delegate tasks to qualified members of the investigation site team but
retains responsibility & must have a list of qualified persons to whom
duties have been delegated
• PI has the final accountability, oversight
• Compliance with the protocol, investigational product, responsible
for the informed consent, safety reporting, keep records and
reports
Adequate resources: for recruiting subjects, qualified staff, adequate facilities
Sub investigator
• Member of the site team, designated and supervised by the Principal
Investigator
• Perform clinical investigation-related procedures or make important clinical
investigation-related and medical treatment decisions
• In general, in EU the term investigator is used for a MD (or dentist) and not
a nurse
2
, Clinical research nurse
-> term not defined -> sometimes called clinical trial nurse, clinical study
nurse
-> involved in data collection and data transcription
-> responsibilities may be difficult depending on the legal definition of
responsibilities of a nurse within a country
Data manager
-> not defined
-> not the data manager as from a sponsor
-> Sometimes a nurse, but can also be an admin support responsible for the
various entries in eCRF (data transcription), interaction with sponsor,
documentation.
Pharmacist
-> Not defined as part of clinical trial regulations or ethical principles
-> Often responsible for the receipt of the investigational product (and
sometimes device)
-> Depending on the organization on site, may be responsible for stock, storage,
drug preparation, distribution, return, accountability …
Other: specialized departments may be involved depending on the trial design
2. Trial-related roles and functions
Which departments/roles are involved in the clinical trial at the
CRO/sponsor?
2.1. Clinic
al operations and project management
Because of the various parties involved in clinical research and all regulations
and guidelines to follow, and because clinical research has to be done within the
3
