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As the study is conducted, the only expected difference between the control and experimental groups in a randomized controlled trial (RCT) is the outcome variable being studied.
• Types of randomized trials/studies
1. Unblinded
2. Single blind
3. Double blind
• The Randomization Module can be very useful when
- Developed and implemented correctly
A. Using a qualified biostatistician to create the allocation tables
2. Accompanied by a documented process for
A. Randomization procedure
B. Unblinding procedure for blinded studies
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Process
• Define the randomization model with various parameters from the project
• Based on the defined parameters, the module creates a template allocation table which can be used to structure your allocation tables you will import
• The module also monitors the overall allocation progress and assignment of randomized subjects
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performed to ensure projects are configured adequately before go live, as randomization errors are very difficult to resolve in Production mode! Projects which are NOT utilizing REDCaps Randomization function, may choose to Randomize outside of REDCap. If this is the case, BMIC randomization review is not required. Simply submit your project production request! (Moving a project to Production)
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Initial Considerations
Randomization is a process that assigns participants by chance (rather than by choice) into specific groups, typically for clinical research and clinical trials.
It is strongly recommended that you have your statistician involved in both the project design as well as development of the allocation tables.
BMIC Randomization review of your project must be requested prior to project go live
Randomization must be set while your project is in Development Mode
Randomization Field must be hosted in a data collection form
REDCap does NOT create the randomization table for you
This table must be generated outside of REDCap using other software (e.g. Excel, SAS, Stata, R). This is usually done by the statistician/data analyst involved in your project. The randomization table must be in Excelformat to be uploaded into REDCap. (An example is provided in REDCap)
Creating your allocation table outside of REDCap lets you choose exactly how you wish to structure your allocations and assignments. REDCap then uses the allocation table as a lookup for determining how to randomize the subjects.
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Planning Randomization is crucial, consider the factors provided below:
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NEVER use the REDCap Template Allocation examples as the allocation tables for your project. They are solely meant to provide examples and NOT to be utilized in a project. Your statistician should create your allocation tables in the format of these template tables. |
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Timing of when to randomize, consider when this will occur in your projects operational workflow… Having Standards of Practice (SOPs) to ensure the integrity of the randomized trial. You should have defined processes for… Your Allocation table needs to be at least 20% larger than your sample size. Major issues can occur mid-study if you have more subjects than spots in your allocation table. A good rule is that for any strata, you should have as many options as the number of participants. For example, if you have 4 strata options, and you plan to enroll 100 participants, you should have 400 slots in your allocation table. This is well over the sample size but ensures you have enough slots. You will need to create two allocation tables, one for development mode (testing) and one for production: A new allocation table must be used for Production, you may NOT use the same table used in development mode. When you have multiple sites, definitely talk to your statistician to ensure you include site in randomization allocation to prevent all controls at one site and treatment at the other site.
NOTE: This article is not meant to supplant any advice you get from your statistician. The size of your allocation table is dependent upon block size, design features, sample size, type of sites, etc.
Determine which type of randomized study will be conducted: Unblinded Single blind Double blind
Define which strata you will be randomizing from (e.g., age, gender). It is a clinically best practice to pipe these fields into your randomization instrument to help you remember the criteria without going back to another instrument. For example, below is a descriptive field which has piped information into the Randomization instrument from a different form so users do not have to navigate back and forth to confirm inclusion/exclusion criteria:  Image AddedCreate a field in REDcap where the data you are randomizing will be piped (as shown above). Do this before configuring your Randomization settings/parameters
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BMIC Randomization Review, Items to have prepared:
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During the randomization review, be prepared to address the following: Project workflow/operations: Be prepared to present an overview of your project purpose, configuration, # participants, recruitment processes, etc. A screen-share will be hosted to provide BMIC team with a walkthrough through of your project workflow, configuration and user rights set up, etc.. Consent process and configuration Inclusion/Exclusion instrument & criteria: Be prepared to showcase your inclusion criteria and how the data is captured Randomization type: Blinded or Unblinded Randomization: Who will perform the randomization? Randomization field & Safeguards: Be prepared to review the instrument where your randomization field is located and show the safeguards you have in place to ensure the Randomization button only appears when a participant meets all inclusion criteria. This can be accomplished using branching logic. For example, if your inclusion criteria is that the participant is over 18 and female, then you would create branching logic for your randomize field which hosts logic that enforces the field only be shown when the participant has selected they are over 18 AND female. More info on branching logic: Branching Logic 101 Be prepare to discuss your allocation table numbers which account for potential attrition
User Rights: Discussion of user rights Users who are Blinded vs Unblinded should have the appropriate user permissions assigned for randomization Consider hiding your randomization instrument from users who should not be granted the ability to randomize
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The Process – Configure REDCap Randomization
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The randomization model is configured via "Project Setup" > “Option modules & customizations” as shown below. Define your instruments and set up your project to be a Randomization Project Turn on the Randomization module by clicking "Enable" on the Project Set-Up page under the section Enable Optional Modules & Customizations  Image Added
Activate User Rights from the left side to ensure you and your staff have access to appropriate rights to assist with the randomized study. Click to activate access to specific Randomization user rights  Image Added
User privileges for randomization • User privileges can be set to allow users 1. Set up randomization 2. Perform randomization 3. View allocation dashboard • Someone with randomize privileges will be able to view and modify existing data used for stratification even if they do not have Forms privileges
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Set up randomization model
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• Once you select this option you will be able to see how the rest of the process occurs
• The BMIC can assist you and your biostatistician with this process
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Final notes about Randomization
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Return to Project Setup page and click on Set Up Randomization  Image AddedREAD the information provided after clicking on More Details
 Image AddedDefine your Randomization model Complete (Step 1) Select your randomization type (stratified is commonly used) Select relevant criteria fields Choose Randomization field Save Randomization model
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Download Demo Allocation Tables (these tables are NOT to be used for your project, examples only)  Image AddedUpload Your Project's Allocation table for the Development instance
TEST your project Move to Production After you have fully tested your project, request that your project be moved to Production. Note that you will need to have your Production randomization allocation table uploaded. The BMIC team will coordinate a meeting to review as noted above to ensure. The Prod excel template
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Additional Considerations
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User Privilege If someone is given 'Randomize' privileges, they will be able to view and modify any existing data already collected for the randomization strata fields (if stratification is used) when they are performing the randomization, even if they do not specifically have form-level rights to view the form on which a strata field exists. Caveat: Randomize rights trump form-level rights in this way, but only for the randomization strata fields.
Extending Allocation Tables
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2. The integrity of any RCT is dependent on everything having SOPs, especially randomization!
Group assignments are assigned based on order of randomization, not enrollment order
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