GDPR you serious?
This term is used to describe any information relating to an identified or identifiable natural person (referred to as the 'data subject'). An 'identifiable natural person' is defined as a natural person who can be identified, directly or indirectly, in particular by reference to an identifier, such as a name, identification number, location data, online identifier, or to one or more elements specific to his physical, physiological, genetic, psychological, economic, cultural or social identity.
What is personal data
It is the expectation that a qualified physician who is an investigator or a sub-investigator for the trial has assessed each individual eligibility criteria and has taken the final decision to include the subject in the trial (ICH GCP 4.3.1). This decision should be documented prior to what event?
This circumstance enables protocol deviations to be initiated without prior written IRB/IEC approval/favorable opinion of an appropriate amendment
What is when necessary to eliminate immediate hazards to the subjects or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change of monitor(s), telephone number(s))
This largest fresh water lake in the world shares borders with these two health authorities
What is Lake Superior and Health Canada, Food and Drug Administration (FDA)
The purpose of this document is to document that trial procedures were reviewed with the investigator and the investigator’s trial staff. A copy of this must be present in the ISF and TMF
What is the trial initiation monitoring report
To reach GDPR compliance, private companies and public authorities that regularly collect and process large amounts of data must employ this position, who is legally obliged to oversee the company’s data activities.
What is the Data Protection Officer (DPO)
These additional four attributes represent the "+" in ALCOA+
What are Complete, Consistent, Enduring, and Available
According to ICH E3, these four categories of protocol deviations constitute important protocol deviations
What are Subjects who entered the trial even though they did not satisfy the entry (i.e. inclusion and exclusion) criteria; Subjects who developed withdrawal criteria during the trial but were not withdrawn; Subjects who received the wrong treatment or incorrect dose; Subjects who received an excluded concomitant treatment
These three regulatory agencies we are working with surround this deepest trench on Earth
What are Health Canada, Food and Drug Administration (FDA), Therapeutic Goods Administration (TGA) and the Pacific Ocean
Per Regulation (EU) No 536/2014, a version of this document that is in plain language and understandable to “laypersons” must be present in the TMF
What is the clinical trial summary report
GDPR legislation applies to businesses operating within this region, and to businesses elsewhere in the world that target people in this region.
What is the EU
The Sponsor is required to have written procedure to handle this type of event. The written procedure must include: receipt and assessment (i.e. assessment of deviations/violations by sponsor/delegate, isolated/systematic incident(s), patient(s) harmed or put at risk, data credibility etc.); investigation including a root cause analysis (this can be ongoing at time of reporting); corrective and preventative action (this can be ongoing at the time of reporting); reporting to the EU CT system; compliance with the 7 calendar day reporting timeline.
What is a serious breach
A series of analyses conducted with the intent to explore the robustness of inferences from the main estimator to deviations from its underlying modelling assumptions and limitations in the data is the definition for what type of analyses?
What are sensitivity analyses
This regulatory agency is home to this lowest (below sea level) lake in the world. Some may say it is salty.
What is the Israel Ministry of Health (MOH) and the Dead Sea
The purpose of this document is to document normal values and ranges that are revised during the trial. A copy of all versions must be present in the ISF and TMF
What are updates to normal value(s)/range(s) for medical/laboratory/technical procedure(s)/test(s) included in the protocol
In the case of a personal data breach, the controller shall without undue delay and, where feasible, not later than this length of time after having become aware of it, notify the personal data breach to the supervisory authority competent in accordance with Article 55, unless the personal data breach is unlikely to result in a risk to the rights and freedoms of natural persons.
What is 72 hours
Verification of this type of data, frequently captured in multiple locations at a site, is a considerable part of the work of monitors, auditors and inspectors. A sufficiently detailed document describing this type of data should be prepared by the site and should be signed and dated by the principal investigator or by a person whom the principal investigator has assigned this task and should be filed in the investigator's trial master file.
What are source data
During a BIMO inspection, this entity is responsible to produce evidence of handling a clinical investigator’s deviations from the protocol and investigational plan or applicable regulations (i.e., determine how deviations are communicated, to whom, and in what timeframe; determine if there is an escalation plan and how escalation is documented).
What is the sponsor
If you rode this world's longest undersea tunnel you would have the ability to connect directly to these two regulatory bodies known for fish and chips and fromage
What is the Chunnel and the Medicines and Healthcare products Regulatory Agency (MHRA), Agence nationale de sécurité du médicament et des produits de santé (ANSM)
This document provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature. It was developed by this group.
What is the TMF Reference Model, Drug Information Association (DIA) Document and Records Management Community
These are the seven principles of GDPR (hint: some have multiple categories).
What are:
1. Lawfulness, fairness, and transparency
2. Purpose Limitations
3. Data Minimization
4. Accuracy
5. Storage Limitation
6. Integrity and Confidentiality
7. Accountability
This section of the DSUR should summarize information on potentially important safety findings that arise after the data lock point but while the DSUR is in preparation. Examples include clinically significant new case reports, important follow-up data, clinically relevant toxicological findings and any action that the sponsor, a DMC, or a regulatory authority has taken for safety reasons.
What is late breaking information
A BIMO inspector will review the sponsor's written procedures on SOP deviations for these four elements
What are detecting, documenting, reporting and fixing the issue
These two regulatory bodies provide SAKIGAKE designation to enable priority review of applications that are submitted to this country located in this ocean
Who are Ministry of Health, Labour and Welfare (MHLW), and Pharmaceuticals and Medical Device Agency (PMDA), Japan and Pacific Ocean
Per the DIA reference model 3.2, records demonstrating sponsor oversight of a specific third party should be filed in the appropriate artifacts of this zone
What is Zone 09