Release Date	Request Code	Change Type	NCI Code	CDISC Term Type	CDISC Codelist (Short Name)	CDISC Codelist (Long Name)	Change Summary	Original	New	Change Implementation Instructions
2018-12-21	CDISC-3612	Add	C101302	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	therapeutic area	
2018-12-21	CDISC-3612	Add	C103246	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	moiety	
2018-12-21	CDISC-3612	Update	C132349	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"A standardized representation of planned clinical trial activities including interventions (e.g., administering drug, surgery) and study administrative activities (e.g., obtaining informed consent, distributing clinical trial material and diaries, randomization) as well as assessments. See also schedule of assessments."	"A standardized representation of planned clinical trial activities including interventions (e.g., administering drug, surgery) and study administrative activities (e.g., obtaining informed consent, distributing clinical trial material and diaries, randomization) as well as assessments. See also schedule of assessments. Compare to study design schematic."	
2018-12-21	CDISC-3612	Update	C132349	CDISC Synonym	CDISC Glossary	CDISC Glossary	Add new CDISC Synonym	- - -	Schedule of Events	
2018-12-21	CDISC-3612	Update	C132349	CDISC Synonym	CDISC Glossary	CDISC Glossary	Add new CDISC Synonym	- - -	SoA	
2018-12-21	CDISC-3612	Update	C137811	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"PRO data initially captured electronically. NOTE: Usually ePRO data is captured as eSource. [DIA ePRO Working Group]. See also patient reported outcome, PRO, eSource."	"Patient reported outcome data initially captured electronically. NOTE: Usually ePRO data is captured as eSource. [DIA ePRO Working Group]. See also patient reported outcome, PRO, eSource."	
2018-12-21	N/A	Update	C142383	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"Any component of a drug product intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals. [Segen's Medical Dictionary]"	"Pharmaceutical dose form for administration to the patient, after any necessary transformation of the manufactured items and their corresponding manufactured dose forms has been carried out. [After ISO 11615 Identification of medicinal products-Data elements and structures for the unique identification and exchange of regulated medicinal product information, Second edition 2017-10]"	
2018-12-21	CDISC-3612	Update	C142418	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"Certification awarded to persons who satisfy the educational and employment requirements and pass an examination conducted by the applied Research ethics national association (aRena), the membership division of Public Responsibility in Medicine and Research (PRiM&R)."	"Persons certified to participate on an institutional review board, who satisfy the educational and employment requirements and pass an examination conducted by the applied Research ethics national association (aRena), the membership division of Public Responsibility in Medicine and Research (PRiM&R)."	
2018-12-21	CDISC-3612	Update	C142476	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"A dimension of data contributing to trustworthiness and pertaining to the systems and processes for data capture, correction, maintenance, transmission, and retention. Key elements of data integrity include security, privacy, access controls, a continuous pedigree from capture to archive, stability (of values, of attribution), protection against loss or destruction, ease of review by users responsible for data quality, proper operation and validation of systems, training of users. NOTE: In clinical research the FDA requires that data relied on to determine safety and efficacy of therapeutic interventions be trustworthy and establishes guidance and regulations concerning practices and system requirements needed to promote an acceptable level of data integrity. [FDA, CSUICI, IEEE]. Compare to data quality."	"A condition of data reflecting the degree to which the data are complete, consistent, accurate, trustworthy, and reliable at any given time as well as consistently so maintained throughout the data life cycle. NOTE: The data should be collected and maintained in a secure manner, so that they are Attributable, Legible, Contemporaneously recorded, Original (or a true copy) and Accurate (ALCOA). Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices. (After MHRA Guidance on ""GxP data integrity"") See also ALCOA, ALCOA+. Compare to data quality."	
2018-12-21	CDISC-3612	Update	C142506	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	define	Define-XML	Updated submission value to more closely describe the term that is being defined by the definition.
2018-12-21	CDISC-3612	Update	C142524	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	eCRT	eCRT (electronic case report tabulation)	Updated submission value to conform to glossary submission value rules for use of parentheticals.
2018-12-21	CDISC-3612	Update	C142524	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"CRTs provided in electronic format for esubmissions (electronic regulatory submissions). NOTE: according to FDA guidance, eCRTs are datasets provided as SAS Transport files with accompanying documentation in electronic submissions. They enable reviewers to analyze each dataset for each study. each CRF domain should be provided as a single dataset; however, additional datasets suitable for reproducing and confirming analyses may also be needed. Becoming obsolete, being replaced by SDTM."	"CRTs provided in electronic format for esubmissions (electronic regulatory submissions). NOTE: according to FDA guidance, eCRTs are datasets provided as SAS Transport files with accompanying documentation in electronic submissions. They enable reviewers to analyze each dataset for each study. Each CRF domain should be provided as a single dataset; however, additional datasets suitable for reproducing and confirming analyses may also be needed. Becoming obsolete, being replaced by SDTM."	
2018-12-21	CDISC-3612	Update	C142525	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	ecertified copy	eCertified copy	Updated submission value for correctness.
2018-12-21	CDISC-3612	Update	C142526	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	eclinical trial	eClinical trial	Updated submission value for correctness.
2018-12-21	CDISC-3612	Update	C142527	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	electronic data capture (EDC)	EDC (electronic data capture)	Updated submission value to conform to glossary submission value rules for use of parentheticals.
2018-12-21	CDISC-3612	Update	C142528	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	activation	activation (EDC)	Updated submission value to more closely describe the term that is being defined by the definition.
2018-12-21	CDISC-3612	Update	C142529	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	electronic health record (EHR)	EHR (electronic health record)	Updated submission value to conform to glossary submission value rules for use of parentheticals.
2018-12-21	CDISC-3612	Update	C142533	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"A computer data compilation of any symbol or series of symbols, executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. [CSUCT Glossary; 21 CFR 11.3(7)]"	"A computer data compilation of any symbol or series of symbols, executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. [CSUICI; 21 CFR 11.3(7)]"	
2018-12-21	CDISC-3612	Update	C142534	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	eSource data (electronic source data)	eSource data	Updated submission value for correctness.
2018-12-21	CDISC-3612	Update	C142537	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	eSource report form (eSRF)	eSRF (electronic source report form)	Updated submission value to conform to glossary submission value rules for use of parentheticals.
2018-12-21	CDISC-3612	Remove	C142589	Term	CDISC Glossary	CDISC Glossary	Remove term entirely from codelist	investigational treatment	- - -	There are many other similar terms in the list that are used more frequently. The team is not sure this is significantly different enough from other terms in the list to justify it as a separate term.
2018-12-21	CDISC-3612	Update	C142602	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"Formal procedure applied by a medicines regulatory agency to grant a marketing authorization, to amend an existing one, to extend its duration or to revoke it. [After ISO 11615:2017, 3.1.43]"	"Formal EU procedure applied by a medicines regulatory agency to grant a marketing authorization, to amend an existing one, to extend its duration or to revoke it. [After ISO 11615:2017, 3.1.43]"	
2018-12-21	CDISC-3612	Update	C142644	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	primary variable	primary outcome variable	Updated submission value to more closely describe the term that is being defined by the definition.
2018-12-21	CDISC-3612	Update	C142644	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"An outcome variable specified in the protocol to be of greatest importance to the primary objective of the trial, usually the one used in the sample size calculation. NOTE: Differences between groups in the primary and secondary variable(s) are believed to be the result of the group-specific interventions. [PR Project; CONSORT Statement] See also primary objective."	"An outcome variable specified in the protocol to be of greatest importance to the primary objective of the trial, usually the one used in the sample size calculation. NOTE: Differences between groups in the primary and secondary variable(s) are believed to be the result of the group-specific interventions. [CONSORT Statement] See also primary objective, outcome, endpoint."	
2018-12-21	CDISC-3612	Update	C142644	NCI Preferred Term	CDISC Glossary	CDISC Glossary	Update NCI Preferred Term	Primary Variable	Primary Outcome Variable	
2018-12-21	CDISC-3612	Update	C142644	CDISC Synonym	CDISC Glossary	CDISC Glossary	Remove CDISC Synonym	"primary endpoint, outcome"	- - -	
2018-12-21	CDISC-3612	Update	C142673	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	retrospective	retrospective data capture	Updated submission value to more closely describe the term that is being defined by the definition.
2018-12-21	CDISC-3612	Update	C142680	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	secondary variable	secondary outcome variable	Updated submission value to more closely describe the term that is being defined by the definition.
2018-12-21	CDISC-3612	Update	C142680	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"The primary outcome is the outcome of greatest importance. Data on secondary outcomes are used to evaluate additional effects of the intervention. [CONSORT statement] See also outcome, endpoint."	"Data on secondary outcomes are used to evaluate additional effects of the intervention. The primary outcome is the outcome of greatest importance. [after CONSORT statement] See also outcome, endpoint."	
2018-12-21	CDISC-3612	Update	C142680	NCI Preferred Term	CDISC Glossary	CDISC Glossary	Update NCI Preferred Term	Secondary Variable	Secondary Outcome Variable	
2018-12-21	N/A	Update	C142707	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	monitoring	study monitoring	Updated submission value to more closely describe the term that is being defined by the definition.
2018-12-21	CDISC-3612	Update	C142710	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	participant	study participant	Updated submission value to more closely describe the term that is being defined by the definition.
2018-12-21	CDISC-3612	Update	C142710	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"A person or entity with a role in healthcare or a clinical study. NOTE: Participants in a clinical trial may include subjects and study personnel. A subject participates as part of the group of people who are administered the therapeutic intervention or control. See also subject, patient."	"A member of the clinical study population from who data are being collected. NOTE: This new term is used with growing frequency in some clinical documents and patient-facing ones like the informed consent form, Plain Language Summaries of study results, and publications. Subject or patient are terms used in regulatory guidelines, databases, other clinical research documents, or systems to refer to study participants. See also human subject, patient, vulnerable subjects, human subject, data subject, clinical research subject, participant."	
2018-12-21	CDISC-3383	Update	C142715	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"Status in a clinical study when a participant agrees to participate following completion of the informed consent process. NOTE: In some cases, when the prospective participant is unable to legally consent, permission to participate may be obtained from their legally-authorized representative. In some cases, enrollment requires verification of eligibility and inclusion in the analysis database. [after Clinicaltrials.gov]"	"Status assigned to a subject who agrees to participate in a study,  following completion of the informed consent process and meeting inclusion criteria. NOTE: Enrollment routinely requires verification of eligibility and inclusion in the analysis database. [after Clinicaltrials.gov]. NOTE: A less common definition assigns enrolled status is the point of enrollment, Can be defined from the signing of an informed consent form. Other ways of defining enrollment or subject status can be specified in some protocols, e.g. non-interventional studies. See also informed consent."	
2018-12-21	CDISC-3612	Add	C156473	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	auxiliary medicinal product	
2018-12-21	CDISC-3612	Add	C156617	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	authorised investigational medicinal product	
2018-12-21	CDISC-3612	Add	C156618	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	authorised auxiliary medicinal product	
2018-12-21	CDISC-3612	Add	C156620	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	clinical trial results registry	
2018-12-21	CDISC-3612	Add	C156621	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	ALCOA	
2018-12-21	CDISC-3612	Add	C156622	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	ALCOA +	
2018-12-21	CDISC-3612	Add	C156623	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	exposure (individual)	
2018-12-21	CDISC-3612	Add	C156624	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	extent of exposure	
2018-12-21	CDISC-3612	Add	C156625	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	manufacturer (device)	
2018-12-21	CDISC-3612	Add	C156626	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	manufacturer (drug)	
2018-12-21	CDISC-3612	Add	C156627	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	medication error	
2018-12-21	CDISC-3612	Add	C156628	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	use error (device)	
2018-12-21	CDISC-3612	Add	C156629	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	anticipated adverse event	
2018-12-21	CDISC-3612	Add	C156630	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	temporary halt (of a clinical trial)	
2018-12-21	CDISC-3612	Add	C156631	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	suspension (of a clinical trial)	
2018-12-21	CDISC-3612	Add	C156632	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	content validation (COA)	
2018-12-21	CDISC-3612	Add	C156633	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	construct validation (COA)	
2018-12-21	CDISC-3612	Add	C156634	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	criterion validation (COA)	
2018-12-21	CDISC-3612	Add	C156635	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	mutual recognition procedure (MRP)	
2018-12-21	CDISC-3612	Add	C156636	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	serious breach	
2018-12-21	CDISC-3612	Add	C156637	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	privacy breach	
2018-12-21	CDISC-3612	Add	C156638	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	accelerated approval	
2018-12-21	CDISC-3612	Add	C156639	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	subject monitoring	
2018-12-21	CDISC-3612	Add	C156640	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	concerned member state (CMS)	
2018-12-21	CDISC-3612	Add	C156641	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	reference member state (RMS)	
2018-12-21	CDISC-3612	Add	C156642	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	marketing authorization	
2018-12-21	CDISC-3612	Add	C156643	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	medicinal product classification	
2018-12-21	CDISC-3612	Add	C156644	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	biosimilar	
2018-12-21	CDISC-3612	Add	C156645	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	AEGIS (ADROIT Electronically Generated Information Service)	
2018-12-21	CDISC-3612	Add	C156646	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	AHIC (American Health Information Community)	
2018-12-21	CDISC-3612	Add	C156647	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	CHI (consolidated health informatics)	
2018-12-21	CDISC-3612	Add	C156648	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	DIBD (development international birth date)	
2018-12-21	CDISC-3612	Add	C156649	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	EDR (electronic document room)	
2018-12-21	CDISC-3612	Add	C156650	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	HIE (Health Information Exchange)	
2018-12-21	CDISC-3612	Add	C156651	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	NOEL (no observable effect level)	
2018-12-21	CDISC-3612	Add	C156652	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	RHIO (Regional Health Information Organization)	
2018-12-21	CDISC-3612	Add	C156653	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	SEND (standard for the exchange of nonclinical data)	
2018-12-21	CDISC-3612	Add	C156663	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	minor	
2018-12-21	CDISC-3612	Add	C156779	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	participant	
2018-12-21	CDISC-3437	Update	C16735	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"An ongoing process that provides the subject with explanations that will help in making educated decisions about whether to begin or continue participating in a trial. informed consent is an ongoing, interactive process rather than a one-time information session. NOTE: Under 21 CFR 50.20, no informed consent form may include any ""language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence."" [ICH] See also consent form."	"An ongoing process that provides the subject with explanations that will help in making educated decisions about whether to begin or continue participating in a trial. informed consent is an ongoing, interactive process rather than a one-time information session. NOTE: Under 21 CFR 50.20, no informed consent form may include any ""language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence."" In some cases, when the prospective subject is unable to provide legal consent, permission to participate may be obtained from a legally-authorized representative. See also consent form."	
2018-12-21	CDISC-3612	Add	C16830	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	medical device	
2018-12-21	CDISC-3612	Add	C17049	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	race	
2018-12-21	CDISC-3612	Add	C17941	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	exposure	
2018-12-21	CDISC-3612	Update	C19984	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"A structured item characterized by a stem and response options together with a history of usage that can be standardized for research purposes across studies conducted by and for NIH. NOTE: The mark up or tagging facilitates document indexing, search and retrieval, and provides standard conventions for insertion of codes. [NCI, CaBIG]. See also item, stem."	"A structured item characterized by a stem and response options together with a history of usage that can be standardized for research purposes across studies conducted by and for NIH. NOTE: The mark up or tagging facilitates document indexing, search and retrieval, and provides standard conventions for insertion of codes. [NCI, CaBIG]. See also item, item (PRO), stem, data element, data element identifier."	
2018-12-21	CDISC-3612	Update	C41161	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	See investigational intervention.	See intervention.	
2018-12-21	CDISC-3612	Update	C42610	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"abbreviation. A set of letters that are drawn from a word or from a sequence of words and that are used for brevity in place of the full word or phrase. NOTE: An abbreviation is NOT pronounced as a word, but each letter is read in sequence (e.g., NIH). Compare to acronym."	"A set of letters that are drawn from a word or from a sequence of words and that are used for brevity in place of the full word or phrase. NOTE: An abbreviation is NOT pronounced as a word, but each letter is read in sequence (e.g., NIH). Compare to acronym."	
2018-12-21	CDISC-3612	Add	C43820	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	MedDRA (Medical Dictionary for Regulatory Activities)	
2018-12-21	CDISC-3612	Update	C45259	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	electronic medical record (EMR)	EMR (electronic medical record)	Updated submission value to conform to glossary submission value rules for use of parentheticals.
2018-12-21	CDISC-3612	Update	C48678	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Biomedical studies not performed on human subjects. [ICH E6 Glossary]	Biomedical studies not performed on human subjects. [ICH E6 (R2)]	
2018-12-21	CDISC-3612	Update	C49686	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"Controlled clinical studies that occur after the completion of Phase 1 studies and the first set of exposure-response studies in patients, and before beginning Phase 2B (i.e., patient dose-ranging trial) and Phase 3 clinical efficacy-safety studies. [FDA draft Guidance for industry end of Phase 2a meetings, 9/08]."	"Controlled clinical studies that occur after the completion of Phase 1 studies and the first set of exposure-response studies in patients, and before beginning Phase 2b (i.e., patient dose-ranging trial) and Phase 3 clinical efficacy-safety studies. [FDA draft Guidance for industry end of Phase 2a meetings, 9/08]."	
2018-12-21	CDISC-3612	Update	C49689	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	phase 3B	phase 3b	Updated submission value for correctness.
2018-12-21	CDISC-3612	Update	C49689	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	A subcategory of Phase 3 trials done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase 3B trials are conducted. These trials may be required as a condition of regulatory authority approval.	A subcategory of Phase 3 trials done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase 3b trials are conducted. These trials may be required as a condition of regulatory authority approval.	
2018-12-21	CDISC-3612	Add	C49704	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	CTCAE (Common Terminology Criterion for Adverse Events)	
2018-12-21	CDISC-3612	Add	C50873	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	overdose	
2018-12-21	CDISC-3612	Add	C53489	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	SNOMED (Systematized Nomenclature of Medicine)	
2018-12-21	CDISC-3612	Add	C53607	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	medical monitoring	
2018-12-21	CDISC-3612	Add	C54390	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	intended use	
2018-12-21	CDISC-3612	Add	C61256	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	monitoring	
2018-12-21	CDISC-3612	Add	C68772	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	surrogate endpoint	
2018-12-21	CDISC-3612	Add	C70755	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	clinical hold (of a clinical trial)	
2018-12-21	CDISC-3612	Add	C70818	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	CUI (common unique identifier)	
2018-12-21	CDISC-3612	Update	C70833	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	Defined by protocol inclusion/exclusion criteria.	Persons enrolled in a study who meet the inclusion/exclusion criteria as specified in the study protocol.	
2018-12-21	CDISC-3612	Update	C70880	CDISC Submission Value	CDISC Glossary	CDISC Glossary	Update CDISC Submission Value	pre-Market approval application (PMA)	pre-market approval application (PMA)	Updated submission value for correctness.
2018-12-21	CDISC-3612	Update	C70880	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	An application to FDA for a license to market a new device in the United states.	An application to FDA for a license to market a new device in the United States.	
2018-12-21	CDISC-3612	Update	C70880	NCI Preferred Term	CDISC Glossary	CDISC Glossary	Update NCI Preferred Term	Premarket Approval Application	Pre-market Approval Application	
2018-12-21	CDISC-3612	Add	C70918	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	Cmax	
2018-12-21	CDISC-3612	Add	C70919	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	Tmax	
2018-12-21	CDISC-3612	Add	C82521	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	other serious (important medical events)	
2018-12-21	N/A	Update	C85826	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"The primary objective(s) is the main question to be answered and drives any statistical planning for the trial (e.g., calculation of the sample size to provide the appro?priate power for statistical testing). [ICH E6 6.3] See also objective."	"The primary objective(s) is the main question to be answered and drives any statistical planning for the trial (e.g., calculation of the sample size to provide the appropriate power for statistical testing). [ICH E6 6.3] See also objective."	
2018-12-21	CDISC-3612	Update	C85838	CDISC Definition	CDISC Glossary	CDISC Glossary	Update CDISC Definition	"Synonym for investigative site, investigator site, site, site of the trial, study site. [ICH E6]"	"The location at which clinical trial activities are conducted. NOTE: Synonym for investigative site, investigator site, site, site of the trial, study site. [ICH E6 (R2)]"	
2018-12-21	CDISC-3612	Add	C98704	Term	CDISC Glossary	CDISC Glossary	Add new term to existing codelist	- - -	adaptive design