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DTRA Podcast

Listen to the Future of Decentralized Clinical Trials by Tuning into “Decentralized: The Decentralized Trials and Research Podcast”

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What Is the DTRA Podcast?

Explore the rapidly evolving world of decentralized clinical trials with expert insights, interviews with industry leaders, and engaging discussions on the latest trends, technologies, and best practices. This is a space for all who want to improve access for clinical research and participation. New topics are covered every week live on Clubhouse with guest speakers in the community talking about the latest ways to make research and clinical trials more inclusive, accessible, resilient, and sustainable by using decentralized methods.


Episodes of the podcast will be made available on demand weekly with additional special episodes throughout the year. Catch the content live on Clubhouse in the DTRA TGIF-DCT house each Friday at 12pm ET.  

The Decentralized podcast is available on Health Podcast Network, a valued partner of the DTRA. You can also find it on Amazon Music, Apple Podcasts, and Spotify.

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Glossary

Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.

A person who gives care to people who need help taking care of themselves. Examples include children, the elderly, or patients who have chronic illnesses or are disabled. Caregivers may be health professionals, family members, friends, social workers, or members of the clergy. They may give care at home or in a hospital or other health care setting

The Continuity of Care Record, or CCR, is a electronic document exchange standard for sharing patient summary information. Also known as: Continuity of Care Document (CCD), Summary of Care Document, Summarization of Episode Note

Individuals involved in the preparation, conduct, monitoring, and negotiation of submission related activities for a clinical trial

A Clinical Research Study is an umbrella term that include interventional and non-interventional studies.

An electronic tracking system that tracks all events (e.g. site contacts) and documents (version and date) relating to the management of a clinical trial or study.

A company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis

Oversees the clinical operations team (CRAs, remote site managers, etc). Responsible for monitoring regulatory and site activities and overseeing participant safety and data integrity. Also commonly referred to as Clinical Operations Lead (COL), Lead CRA, Clinical Team Lead (CTL).

A listed or identified investigator or subinvestigator who is directly involved in the treatment or evaluation of trial participants. This can include Principal Investigators (PIs) and Sub-Investigators (SI/Sub-I)

A Confidentiality Agreement is a legal document between two parties that prevents the release of information, ideas, transaction details, and more to third parties. A Confidentiality Agreement is also known by the following terms: "Non-disclosure agreement (NDA)", "Confidential disclosure agreement"

an administrative process that includes acquiring, validating, storing, protecting and processing required data to ensure the reliability, quality, and timeliness of the data.

A clinical trial utilizing technology, processes, and/or services that create the opportunity to reduce or eliminate the need for participants to physically visit a traditional research site.

Decentralized research methods include technologies (telehealth, wearables, remote clinical assessments) as well as processes (home health, local labs, local imaging, delivery of investigational drug product) used to create the opportunity to reduce or eliminate the need for participants to physically visit a traditional research site

Any study that utilizes decentralized research methods, including observational/non-interventional studies

Direct shipment of clinical supplies and investigational medicinal products (IMP) to the participant’s residence or other agreed upon location (e.g. participant's work)

Companies that provide technology or service solutions for different aspects of DCTs including but not limited to: Trial Technology (e.g., ePRO, eCOA, telemedicine, eICF, Randomized Trial Supply Management, Clinical Supply Depot, EDC) Home Health Services Couriers Labs, Local Imaging Remote or Centralized Monitoring

the collection or distribution of practices, technologies, cultural elements and legal frameworks that are relevant to transactions in any kind of information digitally between different users Also referred to as “shared data”

A form on which investigators or clinical monitors document updates to data that were previously collected.

Status of the final database after agreement by the sponsor is obtained, that all project criteria have been met. Also referred to as a “Hard Lock”.

Electronic capture of a measure that describes or reflects how a participants feels, functions, or survives during a clinical trial Types of eCOAs include: Electronic Clinician-reported outcome (eClinRO) measures Electronic patient-reported outcome (ePRO) measures Electronic Observer-reported outcome (eObsRO) measures Electronic Performance outcome (ePerfO) measures

A health outcome reported by trained healthcare professional after observation of participant’s health condition, collected by electronic methods

A health outcome directly reported by the participant who experienced it and collected by electronic methods

Electronic form that may include multimedia components such as images, audio, videos, diagrams and a digital signature to aid the collection of the informed consent of a participant. Also documents that the patient has been given the appropriate, and not coercive, written information to support their ability to give fully informed consent. Other examples of Consent forms are Assent forms

In clinical trials, an event or outcome that can be measure objectively to determine whether the intervention being studied is beneficial

electronic measurement based on observation made by someone other than the participant or healthcare professional (eg caregiver)

Digital versions of the patient charts in clinician offices, clinics, and hospitals

Electronic version of a patient's medical history and records encompassing information collected about a patient. EHRs focus on the total health record of the patient. They go beyond standard clinical data collected in the provider’s office and are inclusive of a broader view on a patient’s care.

A CRF is a document designed to record all protocol-required information on each subject in a clinical research study. An eCRF (electronic case report form) is a software system used to collect data in a clinical study.

Electronic data capture (EDC) tools provide computerized or automated support for data collection, reporting, query resolution and validation, among other features, for clinical trials. May also include features such as randomization.

A group responsible for adjudicating and validating the investigator’s evaluation of primary and/or secondary endpoints by utilizing a standard methodology; for performing a complete review of potential endpoint-related data; and for ensuring consistency and appropriateness relative to other events adjudicated during the course of the study.

An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format. An eTMF or TMF (trial master file) is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.

Food and Drug Administration, US federal agency responsible for protecting public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products and medical devices.

A form that must be filed by an investigator running a clinical trial to study a new drug or agent. The investigator agrees to follow the U.S. Food and Drug Administration (FDA) Code of Federal Regulations for the clinical trial.

A set of standards and/or guidelines that pharmaceutical and medical device industries use to create/maintain documents.

Hybrid clinical trials describe a suitably flexible scenario that partially eliminates the requirements for participants to visit a physical trial site to perform a protocol-required event that may have traditionally taken place on-site Archetypes of Hybrid trials include (but are not limited to) the following: - Hybrid By Site: Trials where some participants participate at a traditional research site while others engage entirely via decentralized research methods - Hybrid By Visit: Trials where some visits in the protocol require the participant to be seen at a traditional research site, while other study visits can be conducted using decentralized research methods

Home Health care encompasses a wide range of health care services that are given to a patient in their home. A variety of providers may be involved, including but not limited to home health nurses, phelebotomists, doctors, among others. This care is typically provided during Home Health Visits.

Any person who is licensed by a state to provide health care services directly or indirectly to patients, such as a physician, a nurse, a technician, a psychologist, or a lab specialist.

the ability of different information systems, devices and applications (systems) to access, exchange, integrate and cooperatively use data in a coordinated manner, within and across organizational, regional and national boundaries, to provide timely and seamless portability of information and optimize the health of individuals and populations globally

Any investigation in subjects intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational or marketed product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous. Voluntary agreement is given by a person or a person's responsible proxy (a parent/legal guardian) for participation in a study, immunization program, treatment regimen, invasive procedure, etc., after being informed of the purpose, methods, procedures, benefits, and risks. The essential criteria of informed consent are that the participant has both knowledge and comprehension, that consent is freely given without duress or undue influence, and that the right of withdrawal at any time is clearly communicated to the participant. Interventional studies are commonly referred to as Clinical Trials

A clinical trial in which the investigator conceives the research, develops the protocol, and serves as sponsor investigator. Also referred to as "investigator initiated studies (IIS) or investigator initiated trials (IIT).

An independent, neutral body (a review board or a committee, institutional, regional, national or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of trial participants involved in a clinical investigation and to provide public assurance of that protection, by among other things, reviewing and approving/providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving trial participants. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research. Also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB).

A file (either paper or electronic) that contains the essential documents on the site level which individually and collectively permit evaluation of the site conduct and the quality of the data produced. May also be known as Physician Master File, eISF (electronic Investigator Site File).

Voluntary agreement given by a person or a patients' responsible proxy (a parent/legal guardian) for participation in a study, immunization program, treatment regimen, invasive procedure, etc., after being informed of the purpose, methods, procedures, benefits, and risks. The essential criteria of informed consent are that the subject has both knowledge and comprehension, that consent is freely given without duress or undue influence, and that the right of withdrawal at any time is clearly communicated to the patient.

Laboratory collection services which provide participants with alternative options for sample collection that may be closer to home at participating laboratory facilities

The act of overseeing the progress of a clinical trial, ensuring that is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP and applicable regulatory requirements

clinical trial conducted according to a single protocol but at more than one site and therefore carried out by more than one investigator

Communication to study participant through text or other messaging service (ie a study specific app)

The MSL is a highly specialized role within the pharmaceutical, biotechnology, medical device and related healthcare fields. MSLs are clinical experts who concentrate on a specific therapeutic area and are increasingly valuable to pharmaceutical and biotechnology companies based on their clinical and business acumen. They build collegial relationships and disseminate complex scientific and medical information to a wide range of healthcare stakeholders, from HCPs to payers and Key Opinion Leaders (KOLs). MSLs are responsible for activities such as competitive intelligence, congress management, clinical and educational initiatives, and scientific content management. In addition to a high level of scientific training, MSLs also need to be able to build relationships, have strong communication skills across different channels, and have the ability to explain science in an enthusiastic, transparent and engaging manner.

A physician of a drug sponsor responsible for examining and performing medical review of the safety aspects of a clinical trial. Also referred to as Medical Reviewer (MR)

A Health Care Provider (HCP) performing standard of care activities that collect data (such as routine physiologic assessments or routine collection of specimens) that can be used for reference during clinical trials. These activities could be performed at a trial site or remotely.

A non-interventional study (NIS) is an epidemiological study or observation study, in which no study-related intervention is performed on the patient. In the EU this type of study is typically referred to as a Non-interventional study and in the US it's most commonly referred to as an Observational Study

Measurement based on a task performed by participant according to instructions administered by a healthcare professional

Records contain same information as EHRs, but designed to be set up, accessed, and managed by patients

The ability for a patient to take agency over their electronic medical record and choose to share as they deem appropriate

Oversees all aspects of a clinical trial, including day-to-day operations, relationships with Sponsors or vendors and data collection and reporting. Also commonly referred to as a Global Clinical Project Manager.

Any data that could potentially identify a specific individual.

Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

The platform, network, directory structure, database instance and physical boundaries within which real data is collected from a clinical trial

PHI (Protected Health Information) is “individually identifiable health information transmitted by electronic media, maintained in electronic media, or transmitted or maintained in any other form or medium that may identify the patient, including but not limited to: Name and address Date of birth Social security number Payment history Account number Name and address of the healthcare provider and/or health plan

The person(s) in charge of a clinical trial or a scientific research grant. The principal investigator prepares and carries out the clinical trial protocol (plan for the study) or research paid for by the grant. The principal investigator also analyzes the data and reports the results of the trial or grant research

The study protocol is a document outlining the design of a study, describing the objectives, methodology and overall organisation of the research to be carried out forming a template and guide to the research process as a whole

An individual who signed consent form and actively participates in a clinical trial. Also often referred to as "patient" and previously had been referred to as "subject."

The process of reviewing and/or verifying electronic data entry while off site, sometimes in place of on site monitoring. Forms of monitoring can include documentation of conversations with the site, virtual facility tour, that utilize direct EMR access or certificed copies that are uploaded to an approved platform.

An individual who serves as a point of contact for the participating investigative site(s) and who remotely oversee regulatory and site management activities Also commonly referred to as Clinical Trial Specialist (CTS), CTA (Clinical Trial Associate), CMA (Clinical Monitoring Associate), Clinical Site Ambassador (CSA), in-house CRA, or study start-up lead

An observational study that collects data on patients with a specific disease, or a common exposure, or who are receiving a particular treatment.

Responsible for knowing all the regulations that apply to the industry they work in and ensuring that they're followed. The primary function of their work is to review the processes used in their industry and establish guidelines and standards for specific tasks.

Department responsible for ensuring the appropriate licensing, marketing, and legal compliance of pharmaceutical and medical products in order to control the safety and efficacy of products.

To remove PHI or other confidential information from a recorded call or document prior to publication or release to external parties

Any program related to, for example, the testing of the efficacy and safety of pharmaceutical or medical device products, observing the natural history of a disease under standard care practices, or assessing the validity and reliability of a research instrument, which may include, without limitation: (i) Phase I – IV trials; (ii) Health economic programs; (iii) Registries; (iv) Risk Evaluation and Mitigation Strategy (REMS) programs; (v) Knowledge, Attitude and Behavior Surveys; (vi) Focus groups; and (vii) Cognitive debriefings.

Standard operating procedures, detailed written instructions to achieve uniformity of the performance of a specific function

Any information in original records and certified copies of original records of clinical findings, observations or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.

Any report regarding a possible Adverse Reaction/Adverse Drug Experience or special situation like drug exposure during pregnancy, occupational exposure, lack of therapeutic efficacy, overdose, misuse, off-label use, and/or medication errors. Special situation may or may not be associated with adverse reactions.

An individual, company, institution, or organization, which takes responsibility for the initiation, management, and/or financing of a clinical study.

Site staff member responsible for managing clinical research activities and overseeing the day to day operations of clinical trials and studies to ensure that they comply with federal guidelines and institutional policy. They oversee the research process from inception to completion and prepare documentation for institutional review board approval. Also known as Clinical Research Coordinator (CRC), Study Coordinator

A member of the research team designated and supervised by the PI to perform critical study-related procedures and/or to make important study-related decisions

Site feasibility is the process of evaluating the possibility of conducting a clinical trial or study, at a particular site. The monitoring team conducting the feasibility, also ensures that the trial can be conducted at the proposed site from an ethical and regulatory perspective.

Serious adverse event or serious suspected adverse reaction. An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse

The use of electronic information and telecommunications technologies to support and promote long-distance clinical health care, patient and professional health-related education, public health and health administration. Technologies include videoconferencing, the internet, store-and-forward imaging, streaming media, and terrestrial and wireless communications.

Encrypting and transforming PHI (Protected Health Information) or PII (Personal Identifiable Information) into a unique, universal ID number to completely deidentify the collected information across different technology systems. In clinical trials, tokenization is sometimes used to enable patient matching and linkage of RWD from disparate sources.

electronic devices that can be worn or carried on the body to allow personal data of the user to be monitored and measured through smart sensors that are embedded in the device

Method of providing or collecting data to/from participant or trial staff through a web page for specific parts of a study rather than via a mobile (phone/tablet) platform
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