Version

Motivation: Versioning is important for long-term research data management where metadata and/or files attached to a registration are updated over time. It is used to track any metadata or file changes (e.g., by uploading a new file, changing file metadata, adding or editing metadata) once you have published your registration. Once you edit your published registration, a new version history page of this will be created. If you are at version 1 of your registration, depending on the types of changes you make, you would be asked to publish your draft registration as either version 1.1 (ie. minor change) or version 2.0 (ie. major change). For guidelines on what constitutes a major or minor change, please read below.

DOI Structure

The major and minor version numbers described above form the final part of a unique identifier that is associated with your submission.

Registry Fields

(* = Required field)

Part I: Your Study: Information you need to provide at the time when you register

Trial Information

• Trial Title* – Major (unless fixing a typo, etc.)
• Country* – Major
• Region – Major
• Primary Investigator Name* – Major
• Affiliation – Minor
• Email – Minor
• Other Primary Investigator(s) – Major
• Affiliation – Minor
• Email – Minor
• Study Status*
• In Development – Minor
• On-going – Minor
• Completed – Major
• Withdrawn – Major
• Keywords* (ie. sector) – Minor
• Additional Keywords – Minor
• JEL Code(s) – Minor
• Secondary Identifying Numbers (ie. Numbers given to the trial by other funders, sponsors or registries (ClinicalTrials.gov, ISRCT, etc.). – Minor
• Abstract* – Major (unless fixing a typo, etc.)
• External Links – Minor

Dates

• Trial Start Date* – Major
• Intervention Start Date* – Major
• Intervention End Date* – Major
• Trial End Date* – Major

Sponsors & Partners (optional)

• Trial Sponsor(s) – Major
• Trial Partner(s) – Major

Experimental Details

• Intervention(s) – Major (unless fixing a typo, etc.)
• Primary Outcomes (end points)* – Major
• Primary Outcomes (explanation) – Major
• Secondary Outcomes (end points) – Major
• Secondary Outcomes (explanation) – Major
• Experimental Design* – Major (unless fixing a typo, etc.)
• Randomization Method*– Major
• Randomization Unit* – Major
• Was the treatment clustered* – Major
• Sample Size: Planned Number of Clusters (unit of randomization)* – Major
• Sample size: Planned Total number of observations* – Major
• Sample size (or number of clusters) by treatment arms* – Major
• Power calculation – Major

Institutional Review Board (IRB) Information

• Did you obtain IRB approval:
• No – Major
• Yes – Major
• Full Name IRB Board – Major
• Date of IRB Approval – Major
• IRB Approval Number – Major

Docs & Materials (optional)

• Uploading a document – Major

Analysis Plan (optional)

• Uploading a PAP – Major
• Changing the restricted access – Minor

Part II: Information you need to provide when study is complete, withdrawn/abandoned or at key stage of the study

Study Status

• Was this trial withdrawn? [Yes/No] – Major
• No – Minor
• Yes – Major
1. If so, when was the study withdrawn? – Major
2. If so, what was the withdrawal cause? – Major
• Is the intervention completed?:
• No – Minor
• Yes – Major
1. If so, on what date was it completed? – Major
• Is data collection complete?:
• No – Minor
• Yes – Major
1. If so, on what date was it completed? – Major
2. If so, final sample size: Number of Clusters (Unit of Randomization) – Major
3. If so, was attrition correlated with treatment status? [Yes/No] – Major
4. If so, final sample size: Total Number of Observations – Major
5. If so, final sample size (or number of clusters) by treatment arms – Major
6. If so, do all standard errors account for clustering? [Yes/No] – Major
• Is the data available for public use? [Yes/No]:
• No – Minor
• Yes – Major
1. If so, what is the URL? – Major
• Is the data available for restricted use? [Yes/No]:
• No – Minor
• Yes – Major
1. If so, what is the contact email address? – Major
• Are program files posted for public use? e.g. Stata .do files [Yes/No]:
• No – Minor
• Yes – Major
1. If so, what is the URL? – Major
• Is there a preliminary report on results available to share?:
• No – Minor
• Yes – Major
1. Uploading preliminary report – Major
• If you wish, add any working papers or publications – Major

Reports, Papers, & Other Materials

• Relevant paper(s) - is there a working paper or publication available to share?
• Yes – Major
1. Paper abstract – Major (unless fixing a typo, etc.)
2. Paper citation – Major
3. Paper DOI or URL – Major
• Reports & Other Materials – if your document is not previously published, you can upload it to the registry and be issued a citation, using the “Upload a document” button.
• Document Description* – Major
• Document Upload* – Major
• Reports & Other Materials – If your document has already been published somewhere and has been issued a URL and a citation, please use the “Add an external document” button.
• Document Description* – Major
• Paper DOI or URL* – Major
• Citation* – Major