Contents  | 
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Purpose
Record all concomitant medications from baseline as specified in the protocol. If a patient receives treatment or therapy for an adverse event, also record the specific medications or therapies prescribed to treat adverse events on this CRF.
If a patient is taking a medication PRN, do not use a separate line for each time the medication is taken, instead report the first and last dates taken.
Concomitant Measures / Medications eCRF
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Field Descriptions and Instructions
Field Name  | Description / Instructions  | Format  | 
|---|---|---|
Visit Date  | The Visit Date is optional on this case report form. Hit the "Tab" key to leave it empty and move to the Start Date field.  | DD-MMM-YYYY  | 
Course # (d)  | Indicates the course number that this concomitant measure / medication started in as derived from the course initiation start date.  | 5 digits  | 
Day in Course (d)  | Indicates the day since the beginning of course that this concomitant measure / medication started as derived from the course initiation start date.  | 5 digits  | 
Start Date (m)  | Enter the start date of the measure or medication. Note: Partial date is only acceptable for baseline measure or medication.  | DD-MMM-YYYY or MMM-YYYY  | 
Stop Date  | Enter the stop date of the measure / medication. Note: Partial date is only acceptable for baseline measure or medication.  | DD-MMM-YYYY or MMM-YYYY  | 
Agent Name  | In the case of agents, state the generic name of the medication administered, or, in the case of combinations such as trimethoprim / sulfamethoxazole, state the brand name (i.e., Bactrim). Note: This pick list does not show all the Agents. User must type in a search criterion and then click on the ellipsis perform the search and display the resulting matched Agents. Ex: type %ydro% to list all the agents that include the lower characters ‘ydro’ somewhere in the agent’s name. Note: Pre and post medications specified in the protocol and administered as part of the patient's treatment, must be entered in the Study Medication Administration case report form. Note: Do not select an agent name if a procedure has been entered.  | Use pick list.  | 
Procedure /Measure  | If a procedure/measure, state e.g., oxygen administration, pleural tapping, etc. Note: Do not select a procedure if an agent name has been entered.  | Use pick list.  | 
Dose (m) ( 
  | Enter the dose of the agent as appropriate. Note: This field is mandatory for agents. If a procedure/measure, leave blank. 
 Ex: Dose 2, Unit tab, q4hr PRN.  | 100 characters  | 
UOM  | Select the total daily dose units of measurement. Note: If a procedure/measure, leave blank.  | Use pick list.  | 
Schedule  | Enter the frequency of medication administration or measure under schedule.  | 24 characters  | 
Route  | Select the route given:   | Use pick list.  | 
Reason (m)  | Select the reason the medication is being administered or why measure done. For example, if Bactrim is being given as a prophylactic, select "pneumocystis prophylaxis". Note: Do not enter the pharmacological classification of the medication ( e.g. antibiotic, analgesic, etc.)  | Use pick list.  | 
Legend: (d) derived field, (m) RDC mandatory.
Validations
Code  | Description  | Resolutions  | 
|---|---|---|
CM01  | Agent and Procedure are missing.  | An Agent or Procedure must be present.  | 
CM02  | Both Agent and Procedure are filled.  | Agent and Procedure cannot be both selected at the same time.  | 
CM03  | Stop Date is before the Start Date.  | Stop Date must not be earlier than Start Date.  | 
CM04  | Agent entered and Dose and/or Units of Measurement are/is missing.  | If Agent is entered, Dose and Unit of Measurement must be present.  | 
CM05  | Dose and/or Unit of Measurement entered and Procedure also entered.  | If Procedure is entered, Agent, Dose and Unit of Measurement must not be present.  | 
CM06, CM07  | Start and/or Stop Date are/is in the future.  | Enter a date that is equal to or prior to the current date.  | 
CM10, CM11  | Partial Start Date and/or Stop Date are/is after the first Course Initiation Date.  | Partial Start and Stop Dates are only acceptable for baseline measures and/or procedures.  | 
CM12  | Dose is not a valid numeric value.  | Enter a valid numeric value.  | 
Derivations
Code  | Field Name  | Description  | 
|---|---|---|
CM1001  | Course #  | Course number is derived based on the course initiation start dates and the concomitant measure / medication start date.  | 
CM1002  | Day in Course  | Number of days since the beginning of the course is derived from the course initiation start date and the concomitant measure / medication start date.  |