Protocols - Creating a Protocol

Protocol Creation

To start a new protocol simply click the 'New Protocol' button in the top right-hand corner of the Manage Protocols screen and select the appropriate Protocol Type.

Please note, if duplication of a protocol is enabled in the Configuration screen of IRB, IACUC, or IBC then you can also create a new protocol if it's on the active protocol template via the 'Duplicate as New' option in the initial protocol version.

Once initiated the system will guide you through the protocol creation starting with General Information.  Depending on how each institution configures their protocol template the specific fields and requirements for completion may be different.

The Action button of 'Next' guides you through the completion of the preliminary protocol information required before it can be saved.  If you choose to 'Cancel' the protocol will not be saved and the system will return you to the Researcher portal.

After the initial save the user is taken to the General Questionnaire to answer questions required for the protocol.  These questions can all be configured by an institution via the protocol template so they can be unique to your local needs.

After the initial information is completed required to save the protocol record the system will take the user to the entire protocol view so additional information can be added and edited.  For example, this is where you could add the people associated with the protocol, relevant attachments, additional fields, etc.  The layout and available content of the protocol is all customizable via protocol templates.

The +Add Line button allows additional items to be added to the given section.  The Columns button allows a user to configure the columns that display in the given section.

Also, the left-hand side of the screen allows users to easily navigate to the desired sections in the protocol.  This is quick navigation is especially useful if the protocol has numerous sections with large amounts of information within them.

Once the protocol is initially saved you can access it via your researcher portal to resume edit and/or submit the record for review.  All initiated but not submitted protocols will be shown as In Progress in your list.

Notify PI To Submit

If the 'Notify PI To Submit' notification is enabled in configurations there will also be the this action button available to allow protocol collaborators to notify the PI when it's ready to submit.

 

This allows another user to create/complete the protocol on behalf of the PI and then notify them when it's ready for their final review and submission.  This can be used in conjunction with the 'Only the Principal Investigator can do the initial submit on protocols' option in configurations.

When you initially click the 'Notify PI To Submit' it will run form validations first to alert you of any errors you need to correct first.  If there are validation errors you will get a popup window to 'Show me' or 'Notify PI Anyways' to send a notification to the PI without addressing the errors.  

If there are no errors on the validation check it will send the 'Notify PI to Submit' notification set up in your Configurations.