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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.
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.
| DD-MMM-YYYY or MMM-YYYY | |||
Stop Date | Enter the stop date of the measure / 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).
| Use pick list. | |||
Procedure /Measure | If a procedure/measure, state e.g., oxygen administration, pleural tapping, etc.
| Use pick list. | |||
Dose (m) (
| Enter the dose of the agent as appropriate.
Ex: Dose 2, Unit tab, q4hr PRN. | 100 characters | |||
UOM | Select the total daily dose units of measurement.
| 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".
| Use pick list. |
Legend: (d) derived field, (m) RDC mandatory. |
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. |
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. |