Standard Milestone Types

This article provides definitions for standard Milestone Types. These milestones define critical checkpoints throughout the study to ensure consistent tracking and reporting.

The following standard Milestone Types are available:

Milestone Type Label	Milestone Type Name	Milestone Type Definition
Close Out Monitoring Visit	close_out_monitoring_visit__ctms	The final visit to the site has been performed to ensure all trial activities are completed, investigational product has been reconciled, and data is finalized.
Country Financial Templates Ready	country_financial_templates_ready__v	The country contract and budget templates have been finalized and are ready for use.
Country Packet Ready	country_packet_ready__v	The country-specific regulatory packet of key study documents is ready for distribution to sites within that country.
Country Selected	country_selected__v	A country has been selected for inclusion in the study.
EC/IRB Application	ec_irb_submission__v	The study was submitted to the EC/IRB for approval to conduct the study and a decision was received.
EC/IRB Approval	ec_irb_approval__v	The EC/IRB has indicated that the study can proceed, having met all ethical and regulatory requirements.
EU CTR Country Approval	eu_ctr_country_approval__v	The clinical trial has been approved under the EU CTR to conduct the study within the given country.
EU CTR Part I Application	eu_ctr_part_i_application__v	Submission of the Part I Application under the EU CTR, including the core study documents and data, and a decision was received.
EU CTR Part II Application	eu_ctr_part_ii_application__v	Submission of the Part II Application under the EU CTR, including the core study documents and data, and a decision was received.
Feasibility Survey Completed	feasibility_survey_completed__v	The site has submitted answers to the feasibility questionnaire and confirmed their capabilities as it relates to conducting the trial.
Final Database Lock	final_database_lock__v	The completion of all data entry and validation processes has occurred, officially locking the study database and starting statistical processing.
Final Tables Ready	final_tables_ready__v	All statistical tables, figures, and listings summarizing study results are complete and ready for the final study report.
First Country Site Initiated	first_country_site_initiated__v	The first site in the country has opened for enrollment of study participants.
First Site Initiated	first_site_initiated__v	The first site in the study has opened for enrollment of study participants.
First Subject Consented	first_subject_consented__v	The first participant in the study has provided informed consent to participate.
First Subject In	fsi__ctms	The first participant in the study has been enrolled.
First Subject Out	first_subject_out__v	The first participant in the study has completed all study activities, including follow-up.
First Subject Randomized	first_subject_randomized__v	The first participant in the study has been randomized for placement in a treatment group.
First Subject Screened	first_subject_screened__v	The first participant has been assessed for eligibility in the study.
First Subject Started Follow Up	first_subject_started_follow_up__v	The first participant has begun their follow-up period in the study.
First Subject Started Treatment	first_subject_started_treatment__v	The first participant has begun their treatment regimen in the study.
First Subject Treated	first_subject_treated__v	The first participant in the study has completed treatment.
Health Authority Application	ha_application__v	The study was first submitted to a health authority for approval to conduct the study under its purview and a decision was received.
Health Authority Approval	ha_approval__v	The health authority has given its first approval for a study to be conducted under its purview.
Interim Analysis	interim_analysis__v	A statistical analysis to evaluate treatment effects and monitor for any significant findings or safety concerns has been performed.
Interim Monitoring Visit	interim_monitoring_visit__ctms	A scheduled visit to the study site has been performed to review progress, verify data accuracy, and ensure protocol compliance.
Key Country Docs Complete	key_country_docs_complete__v	All essential documents required for the initiation of the country have been finalized and approved.
Key Results Ready	key_results_ready__v	Primary study outcomes and critical data analyses are complete and available for reporting.
Key Study Docs Complete	key_study_docs_complete__v	All essential documents required for the initiation of the study have been finalized and approved.
Last Subject Consented	last_subject_consented__v	The last participant in the study has provided informed consent to participate.
Last Subject In	lsi__ctms	The last participant in the study has been enrolled.
Last Subject Out	lso__ctms	The last participant in the study has completed all study activities, including follow-up.
Last Subject Randomized	last_subject_randomized__v	The last participant in the study has been randomized for placement in a treatment group.
Last Subject Screened	last_subject_screened__v	The last participant has been assessed for eligibility in the study.
Last Subject Started Follow Up	last_subject_started_follow_up__v	The last participant has begun their follow-up period in the study.
Last Subject Started Treatment	last_subject_started_treatment__v	The last participant has begun their treatment regimen in the study.
Last Subject Treated	last_subject_treated__v	The last participant in the study has completed treatment.
Other Country Application	other_country_application__v	Relevant study-related information has been submitted to the relevant authorities at the country level and a decision was received.
Other Country Approval	other_country_approval__v	The relevant authorities have given their approval of the related country submission.
Other Site Application	other_site_application__v	Relevant study-related information has been submitted to the relevant authorities at the site level and a decision was received.
Other Site Approval	other_site_approval__v	The relevant authorities have given their approval of the related site submission.
Oversight Monitoring Visit	oversight_monitoring_visit__v	A quality oversight and relationship management activity has been performed by the Sponsor to evaluate CRA performance, strengthen the Sponsor-Site partnership, and verify that trial conduct protects subject safety and the reliability of trial results.
Pre Study Monitoring Visit	pre_study_monitoring_visit__ctms	The visit to the study site to assess its readiness, capabilities, and resources for conducting the study has been performed.
Protocol Amendment	protocol_amendment__v	A formal revision has been performed on the effective protocol that has modified aspects such as the study design, eligibility or procedures, which may require approval by regulatory authorities and ethics committees.
Protocol Approval	protocol_approval__v	Formal endorsement of the study protocol was granted by the relevant committee or body, allowing the study to proceed.
Protocol Concept Approved	protocol_concept_approved__v	Initial approval of the study concept has been received from the relevant stakeholders, allowing the development of a detailed protocol.
Site Activated	site_activated__v	The site was opened for enrollment of study participants.
Site Contracts Executed	site_contracts_executed__v	All financial documents, including budget and contracts, pertaining to participation in the study by the site have been executed.
Site EC/IRB Application	site_ec_irb_application__v	The study was submitted to the IRB/EC for approval to conduct the study at the site level and a decision was received.
Site EC/IRB Approval	site_ec_irb_approval__v	The EC/IRB has indicated that the study can proceed within the given site, having met all ethical and regulatory requirements.
Site Essential Docs Completed	site_essential_docs_completed__v	All required regulatory and study-related documents for a site have been finalized and approved.
Site Greenlight	site_greenlight__v	Approval was granted for the investigational product to be released to a site.
Site Initiation Monitoring Visit	siv__ctms	A visit to the site has been performed to train site staff, confirm all systems and supplies are ready, and verify regulatory compliance prior to participant enrollment.
Site Qualified	site_qualified__v	Confirmation that a study site has met all necessary criteria and requirements to participate in the study.
Site Regulatory Packet Sent	site_reg_packet_sent__v	The complete set of regulatory documents required for a site has been compiled and sent to the site.
Site Selected	site_selected__v	A site was selected for participation in the study indicating that startup and initiating activities can commence.
Study Financial Templates Ready	study_financial_templates_ready__v	The study contract and budget templates have been finalized and are ready for use.
Study Report Submitted	study_report_submitted__v	The final clinical study report summarizing study results and conclusions was submitted to the regulatory authorities.