Why should I register my research?
It’s ethical to do so. The World Medical Association’s Declaration of Helsinki 2013 states: “Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.” Its also an important part of compliance with many reporting guidelines for various types of research studies.
How do I get my Unique Identifying Number (UIN) once I register a study or review?
How should I cite my UIN?
What studies should be registered on the Research Registry?
All research studies, from “first-in-man” studies (i.e. the first case report of a novel technology or surgical technique) to observational studies like case series and cohort studies to interventional studies including randomised controlled trials. The Review Registry (also available on this website) publishes specifically systematic reviews and meta-analyses. We do not register case reports that are not first-in-man or animal studies. If your study is deemed inappropriate, it will be removed through the weekly data curation process.
When should I register a study?
Before recruitment of the first participant. Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires applicable clinical studies to be registered within 21 days of enrollment of the first participant. In addition, the International Committee of Medical Journal Editors (ICMJE) and other journals require registration of clinical studies prior to enrollment of the first participant. However, the Research Registry will not only register research prospectively (as is best practice), but also retrospectively. This is because if a study is not prospectively registered, subsequently performed and then rejected by a journal and not published, no record of it will exist. We wish to address this by allowing retrospective registration for all those studies not prospectively registered prior to recruitment of the first participant and which have not yet been published in a journal.
I’ve already started my study, but haven’t registered, what should I do?
Ideally, you should register before recruitment of the first participant. However, you can still register at the Research Registry even if you have already started recruitment or even completed your study.
Who should register the trial?
The primary investigator or someone they have nominated.
What data do you collect?
We collect the WHO’s 20-item minimum data set but also collect additional items we feel are relevant.
Can I change or update any information provided after submission to the registry?
Yes you can login and make updates to your entry. The guidebook provided here can show you how to do this.
Can I add results to my study? What should I include?
Yes, every entry has a box for adding results and you can use the update process shown in the guidebook to add them once you have them.
Post Study Results (once available) should consist of:
1 – Date of posting of results summaries.
2 – Date of the first journal publication of results.
3- URL hyperlink(s) related to results and publications.
4 – Baseline Characteristics: Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age and sex, and study-specific measures.
5 – Participant flow: Information to document the progress and numbers of research participants through each stage of a study in a flow diagram or tabular format.
6 – Adverse events: An unfavourable change in the health of a participant, including abnormal laboratory findings, and all serious adverse events and deaths that happen during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied.
7 – Outcome measures: A table of data for each primary and secondary outcome measure and their respective measurement of precision (eg a 95% confidence interval) by arm (that is, initial assignment of participants to arms or groups) or comparison group (that is, analysis groups), including the result(s) of scientifically appropriate statistical analyses that were performed on the outcome measure data, if any.
8 – URL link to protocol file(s) with version and date.
9 – Brief summary
Are you affiliated with the WHO?
Only national registries can be registered with the WHO. The Research Registry independent and global and not affiliated with any one particular country.
Which organisations does the Research Registry work with?
The Research Registry is a member of the Health Research Authority’s Research Transparency Forum and also works with and is endorsed by the IDEAL Collaboration, a group working to improve the quality of surgical research.
What will you do with my email address?
We will use your email address to get in contact with you, and if others have queries regarding your research they can also contact you via the details in the form. We will never sell your email address to third parties.
I am having trouble logging in, can you help?
Click forgot password if you forgot. Also try emptying your browser cache and retrying. If nothing happens, maybe you never set the account up in the first place. Set up a new account.
What is the cost of registering a study?
The Research Registry was free to register since launch in January 2015. From April 2018, we will begin charging a small fee (shown at the bottom of the registration page) to help cover the costs of technical development, IT/infrastructure costs, staff time/development, ensure quality control/data curation and marketing. Presently this fee is £99. There are no refunds for those studies that meet our criteria for inclusion.
How is the Research Registry funded?
Currently the Research Registry is funded by the IJS Publishing Group. It has no ties to industry or government.
How long does it take to register?
Once you complete the form (less than 5 minutes if you have the information ready to copy into the fields) and submit it, your UIN will be available immediately and shown in the register.
Are there risks in my registering?
Some researchers have expressed concerns with registries in general – that others can copy their protocol. This is easier said than done on the basis of the registration entry alone. Such individuals would need the knowledge, skills, infrastructure, equipment and relevant personnel to do it. Most importantly it would be a gross violation of research integrity and ethics and such an individual could be reported to their institution who may have to open an investigation.
I registered my work and now the entry has been deleted?
A common cause of this is registering a case report where a surgical technique is deployed, but it not first in man. Erroneous entries are also deleted.
How do I search the Research Registry?
Go to the database and click in the search bar and enter the relevant keyword.
What is the technology infrastructure behind the Research Registry?
The ResearchRegistry.com is built around a cloud infrastructure designed to maximize availability, reliability, and security.
- Data Storage: MongoDB
- Data Encryption: all data transfer is encrypted with SSL at each transfer stage.
- Data Indexing: Solr
- Application Processing: Node.js
- Servers: Amazon Web Services (cloud computing services)
- Redundancy: All of the application rendering and processing is done with failover and load balancing in place. The Mongo data stores are replicated on additional servers in different locations for higher availability.
- Backups: Multiple backups of all app data are securely made daily to both on and offsite locations.
- Scalability: We use a distributed cloud-based system, which means that scalability can be achieved by simply adding capacity as needed. Record size or bandwidth usage has no impact on performance.
What are your terms and conditions?
Downloading or viewing data on the Research Registry indicates your acceptance of the terms and conditions of the cite.
- Registration on the site is not an endorsement of the work.
- The Research Registry is updated daily, you should refresh your browser when viewing data to ensure you have the latest version.