Concomitant medications eCRF that data managers do not have to rewrite
Every medication a participant takes besides study treatment, recorded once as a log row with structured dose, unit, route and frequency. The form most prone to free-text chaos, built so it codes cleanly.
- Repeating log rows
- Structured dose and frequency
- Partial start dates
Free sandbox · No credit card · 21 CFR Part 11 aligned
Medication (trade or generic name)
CMTRTIndication
CMINDCDose
CMDSTXTRoute
CMROUTEFrequency
CMDOSFRQStart date
CMSTDATPartial date accepted
Ongoing?
CMONGOWhat this template gives you
- A log form: one row per medication course, updated when it stops or changes, with each row carrying its own field-level audit trail.
- Structured fields for dose, unit, route and frequency instead of one free-text line such as "atorvastatin 20mg od", so exports tabulate and coding is fast.
- Prior and concomitant medications in one log, separated by start date relative to consent or first dose, as your protocol defines.
- Fields follow CDASH-style names (CMTRT, CMINDC, CMROUTE, CMDOSFRQ) and the form carries the SDTM CM domain label.
- Pairs with the adverse event eCRF: a treated AE should have a matching con med.
Why it matters
The form where free text goes to die
Concomitant medications are recorded at almost every visit of almost every study, and they are among the hardest data to clean. The same drug appears as a brand name at one site and a generic at another, doses arrive as "1 tab" or "20mg" or "twenty milligrams", and frequencies range from "od" to "once a day" to "every morning". Before any of it can be analysed, someone has to standardise it and code it to a drug dictionary.
A good con med form moves that standardisation to the point of entry. The drug name stays free text (it is coded later, usually with WHODrug), but everything else is structured: dose as a number, unit and route from controlled lists, frequency from a dropdown, dates as dates. Coders then work with clean inputs, and prohibited-medication checks become possible.
Prior versus concomitant
Protocols usually ask for medications taken within a look-back window before screening (prior medications) and everything taken during the study (concomitant). Keeping them in one log with start and end dates lets analysis classify each row, rather than asking sites to choose between two forms and sometimes picking the wrong one.
Coding
Drug names are normally coded to WHODrug for analysis. Keep the verbatim name exactly as recorded so the coded term can always be traced back to what the site entered. Coding usually happens in data management, after entry, not at the site.
| Free text | Structured | |
|---|---|---|
| Dose tabulates | ||
| Frequency comparable across sites | ||
| Prohibited meds checkable | ||
| Coding effort | High | Low |
Field specification
Fields in the concomitant medications template
| Field | Variable | Question type | Notes |
|---|---|---|---|
| Medication name | CMTRT | Text | Verbatim; coded to WHODrug later. |
| Indication | CMINDC | Text | Link to medical history or AE where relevant. |
| Dose per administration | CMDSTXT | Number | Numeric only; unit in its own field. |
| Dose unit | CMDOSU | Dropdown | mg, mcg, g, mL, IU, tablet, puff and more. |
| Route | CMROUTE | Dropdown | Oral, IV, SC, IM, topical, inhaled, other. |
| Frequency | CMDOSFRQ | Dropdown | QD, BID, TID, QID, PRN, weekly, other. |
| Start date | CMSTDAT | Date | Partial dates accepted. |
| Ongoing? | CMONGO | Single choice | Drives whether an end date is expected. |
| End date | CMENDAT | Date | Not before start date. |
| Taken for an adverse event? | Sponsor-defined | Single choice | Prompts cross-check with the AE log. |
CDASH-style variable names; the form carries the SDTM CM domain label. Not a validated SDTM transformation.
Log form
One row per course, however many visits it spans
Most medications continue across many visits. The log form holds one row per course: sites update the end date when a drug stops and add a new row when the dose changes, instead of re-entering the whole list at every visit. Each row has its own audit trail, so every change is traceable.
- Repeating rows, each with its own field-level audit trail.
- Reviewed at every visit and updated rather than re-entered.
- Con-med listings in the reports menu for medical review.
Prohibited medications
Flag prohibited medications as they are entered
Many protocols prohibit specific drugs or classes during the study. With structured entry, the review is straightforward: data managers review con-med listings against the protocol list, and where a prohibited medication is found it is handled as a protocol deviation. Custom-value checks can also flag specific answers, such as a "Yes" to a question about rescue or prohibited therapy.
- Con-med listings for data manager and medical monitor review.
- Deviations logged and tracked through to resolution.
- Queries raised in context from the field.
Add the con meds log to a sample study
Copy the template from the library and enter a few test medications.
Before you approve
Con meds form checklist
Look-back window defined
How far before screening prior medications are collected.
Unit and route lists reviewed
Controlled lists cover what your population actually takes.
Prohibited list available
Protocol list shared with sites and data management.
Coding plan
Dictionary and version named in the data management plan.
Completion guidelines
When to add a row versus update one, written down.
Link to AEs
Treated AEs cross-checked against the log before lock.
What is a concomitant medications CRF?
The form sites use to record medications a participant takes alongside study treatment, and usually prior medications within a look-back window.
Should dose be free text?
No. Record the dose as a number, with unit, route and frequency as controlled lists. It makes the data countable and coding faster.
How are medications coded?
Usually to WHODrug, by data management after entry. The verbatim name is kept alongside the code.
Should prior and concomitant medications be separate forms?
One log with start and end dates is usually simpler; analysis classifies each row relative to consent or first dose.
Is the template free?
Yes. It is in the Capture template library, available in the free sandbox.
Keep exploring
Related pages
Adverse event eCRF template
The log it pairs with.
Medical history eCRF template
Indications and baseline conditions.
How to design an eCRF
Log forms and field types.
Clinical data management
Listings, queries and lock.
Protocol deviation tracking
Prohibited medication deviations.
What is a CRF?
Case report forms explained.
Con meds that code themselves, almost
Structured log, partial dates and audit trail. Free sandbox.