Drugs/Biologics/Dietary Supplements

 

The initial questionnaire for new protocol creation will ask the submitter if the study involves the use of any agents, as shown below.

 

 

If the submitter answers ‘Yes’ to this question, or later adds the Drugs/Biologics/Dietary Supplements form to the study using Add/Delete Forms, then a 2-step process to select or add the Agent to the database and complete the form will follow.  The same process will be used for adding/modifying any agents during an amendment.

 

In this screen shot below, Ibuprofen has already been added to the study.  At this point, the submitter can add another drug by clicking the ‘Add Agent’ link or remove Ibuprofen from the study through the Add/Delete Forms page. 

 

Note: If the user answered ‘No’ to the Drug question on the initial questionnaire, the ‘Add Agent’ link will not appear unless the Drug form is first added through the Add/Delete Forms page.

 

 

To add a new drug from the Forms page, click on the ‘Add Agent’ link; this will launch a drug search page allowing the user to search and select a drug.  If the drug cannot be found, the user can add the new drug directly through the page.

 

Drugs can be searched for using any one of the categories by selecting the appropriate radio button:

 

To search for a drug, select the appropriate radio button and enter any amount of letters in the ‘name of agent’ text box.  Click the ‘Search’ button for results.  The list box will display the name and manufacturer of all applicable results for your search.  The manufacturer is displayed in all caps and in brackets.  If the user selects a drug from the list, the ‘Next’ button will navigate the user to the Drug form for completion of the drug information for the protocol.  The drug form will be pre-populated with the name of the drug and the manufacturer that was displayed in the search results.

 

If the correct drug and manufacturer is not found in the search results, the user can check the ‘Add New Agent’ checkbox and provide the requested information.  The ‘Add New Agent’ check box will not be enabled unless the user first searches for the drug.

Select an Agent:

In the screenshots below, the user has searched for the drug using specific search criteria and clicked the ‘Next’ button to navigate to the Drug form to complete the information for Desyrel.

 

 

Add New Agent:

When the submitter checks the ‘Add New Agent’ checkbox, the data fields to be manually entered by the submitter will be displayed on the page.

 

The following information will be requested for any new agent:

 

Required fields are one of the three Name fields, Manufacturer and the Type of Agent (Drug, Biologic or Other.)  The ‘Next’ button will bring up the Drug questionnaire for the submitter to complete the Drug form regarding the use of the drug in the research study.  The drug name associated with the new drug questionnaire will be that specified by the radio button selection.

 

In the screenshot below, the user has clicked on the ‘Add New Agent’ checkbox and completed the information for adding a new Investigational Drug.  The user then clicks the ‘Next’ button to navigate to the Drug form to complete the information for the drug named Investigational 1.