Who/What Am I?
I am appointed by the study sponsor and oversee the progress of a clinical trial, and ensure that it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and the applicable regulatory requirement(s).
Who is the Monitor?
The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.
What is Randomization?
QA
What is Quality Assurance?
Principle 2.9: What must be obtained from every subject prior to clinical trial participation?
What is (freely given) informed consent?
The regulatory agencies of Japan, the United States, and Europe follow these standardize set of guidelines.
What are ICH Guidelines?
Drug accountability at the clinical trial investigational site rests with me.
Who is the Investigator?
Original documents, data, and records (e.g., hospital records, charts, laboratory notes, diaries).
What are Source documents?
The P in CAPA.
What is Preventative?
Principle 2.5: Clinical trials should be scientifically sound and described in a clear _________ _____________.
What is a detailed protocol?
To ensure appropriate use of the investigational product(s), the investigator must be familiar with these two documents.
What are the protocol and the investigator's brochure?
What has the purpose to document that consent is obtained in accordance with GCP and the protocol and dated prior to participation of each subject in the trial?
What are signed informed consent forms?
A a document research personnel sign to attest whether any outside interests may unduly influence their professional judgement.
What is Conflict of Interest or Financial Disclosure?
ALCOA-C
What is attributable, legible, contemporaneous, original, accurate, and complete?
Principle 2.2: Before a trial is initiated, foreseeable _______ should be weighed against the anticipated ____________.
What are Risks and benefits?
Name two records that could be source documents.
What are ....
Hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries of evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial
I am responsible for ongoing safety evaluation of the Investigational Product.
Who The Sponsor (5.16.1)?
Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
What are Essential Documents?
CTMS
What is a Clinical Trials Management System?
According to ICH GCP, Clinical trials should be conducted in accordance with the ethical principles that have their origin in _______________ ?
What is The Declaration of Helsinki?
A collection of the essential documents to record that the obligations for a clinical trial are fulfilled.
What is a Trial Master File or Regulatory Binder?
A group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup.
What is an institutional review board (IRB)?
A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects.
What is the Investigator's Brochure?
GLP
In human research, what should prevail prevailing over interests of science and society?
What are the rights, safety, and well-being of participants?
What does ICH stand for?
What is the International Council for Harmonization?
(fine if they say International Conference on Harmonization, which it was prior to 2016)