Table 2.

Existing registry—suitability assessment.

Requirements	Recommendations	Suggested practices
Registry must be able to support the proposed clinical trial	The existing registry is appropriately focused on the patient population, disease, and intervention of interest Historically, the evidence collected within the registry is robust (see Table 1) Historically, the evidence collected within the registry is reliable (see Table 1)	See Table 1 for recommended assessment of a registry for use as the data collection platform for conducting prospective randomized clinical trials, including assessment of applicability, strengths, and weaknesses based on historical use
Registry data must be fit for purpose (relevant)	Assignment of therapy: Processes must be integrated for identification, assignment, and documentation of eligible participants	Assess ability to incorporate methods required for identification of study-appropriate patients Evaluate ability to embed processes for randomization into registry workflow Evaluate ability to embed processes for assurance and documentation of informed consent
	Adequacy of data: Assure available data elements collected in the registry generate the information/evidence needed to answer the question at hand	Supplement missing and/or longitudinal data elements needed for evidence generation through the use of modular add-on datasets or linkages to other datasets The eventual goal should be linkage to the EHR for procedural and long-term data collection and incorporation of data collection into the normal workflow
	Ensure availability of appropriate data and analysis tools	Identify analysis tools necessary to allow the data collected within the registry to generate interpretable results (i.e., evidence)  Develop pre-specified endpoints and a statistical analysis plan  Consider suitability of the totality of the data (i.e., body of evidence supporting the clinical benefit-risk assessment)
Registry data must be of sufficient quality (reliable) to support a prospective clinical trial	Data collection must be sufficient to support regulatory decision-making	Assess the adequacy of the registry’s data collection form as a CRF
	Data should be complete and accurate	Assure appropriately trained personnel are available at study sites for data collection and abstraction Registry should incorporate use of a uniform data dictionary Registry should incorporate appropriately defined timing for collection of key data points
	Employ adequate data quality assurance procedures	Assess the need for enhanced auditing and monitoring of data to assure completeness and accuracy
	Establish processes for accountability of study patients	Minimize patient withdrawals Minimize patients lost to follow-up
	Source data should be available for key data elements; site-reported data without independent assessment may not provide enough accuracy for key outcomes in randomized trials	Use independent assessors for key data, such as:  Independent blinded core labs when needed for data interpretation  Clinical Events Committee when needed for adjudication of key outcomes and adverse event data
Registry data and evidence generated must be accessible, with adequate provisions for patient privacy and data confidentiality	Establish data availability to the sponsor and/or clinical investigators, with considerations for patient privacy and data confidentiality	Assure informed consent adequately describes data accessibility and maintenance of patient privacy and data confidentiality Assure accurate identification of all study-enrolled patients within registry Assure ability to sequester records of study-enrolled patients (i.e., patient privacy and data confidentiality) Define timing and timeliness of sequestered record transfer for sponsor (i.e., product-specific proprietary data) Define timing and timeliness of data transfer to analytic dataset
	Ensure availability of line-item data to regulators	Define timing and timeliness of data and analysis transfer to regulators
	Establish necessary associations to other data sources	Determine and provide the necessary linkages to other registries, administrative or government databases, EHRs, etc. Identify new records generated in linked databases for longitudinal follow-up of patients enrolled in research studies
	Develop plan for data dissemination	Define timing and timeliness of data transfer to the study sponsor(s) for dissemination of outcome analyses to study participants and participating physicians As appropriate, define process for release of data and analyses to other stakeholders (e.g., clinicaltrials.gov, payers, etc.)

CRF case report form, EHR electronic health record