|Lack of comprehensive list of RCHD sources and the data they hold||There is no one point where you can find out about all sources of RCHD.||A searchable database – HDR UK or NHS Digital is responsible for update.|
|Clear terminology to describe data from registries||The source of the trial data is not always mentioned in trial publications.||Publication of consensus terminology and a description of the way in which RCHD can be used.|
|Publications of trials using RCHD did not make mention of it.||In methods section, details of the sources of RCHD should be stated.||Soon-to-be-released EHR CONSORT extension for routinely collected health data should improve this.|
|Lack of awareness by trialists of the availability and utility of RCHD||Shown by a small percentage of trials using RCHD||More publicity on available RCHD and the use of RCHD|
|Poor accessibility of data||Registry name change invalidating consent|
Long delays of several years in application process
RCHD not provided despite agreement
|Streamline the RCHD application process and render it efficient.|
|Poor data retention and no possibility of onward sharing||Time limit to keeping the data is shorter than the data storage time limit for the trial.|
Data sharing is often necessary to achieve funding for a trial.
|RCHD needs to align with trial data retention rules and data-sharing requirements.|
|Data quality and timeliness||Trial data are monitored and checked and a lot of registry data are not.||Registry data need a validation process to ensure that their RCHD can be used as a verifiable GCP-compliant data source.|
A comparison of trial and registry data in several trials, facilitated by a SWAT, is required to educate all about the accuracy and completeness of registry data.
|Regulator ready RCHD||Trial data require underlying source data whilst registry data are not source data and do not often have checked underlying source data.||Regulators and registries need to agree a solution to underlying source data.|