1. MedDRA Coding for Adverse Event (AE) Logs

2. MedDRA Coding to SOC Level for AE Logs
MedDRA (the Medical Dictionary for Regulatory Activities) is the most commonly used dictionary for coding (ie, classifying under different headings) Adverse Events (AEs) in clinical research.
MedDRA has a hierarchy of descriptive terms. The System Organ Class (aka “SOC”) is the highest term. There are only 27 of these highest-level SOCs (whereas there are thousands of terms lower down in the hierarchy).
To meet EudraCT reporting requirements, it is now necessary to provide the MedDRA SOC code for each AE reported in a clinical trial. This is best done as and when the AE is logged, and is a simple process that can be run using the MedDRA web-based tool that ACCORD subscribes to.

3. MedDRA Coding to SOC Level for AE Logs
Log on to MedDRA here:
You will see this login page:
ACCORD will provide you with an ID and password to enter (contact ).

4. MedDRA Coding to SOC Level for AE Logs
The web interface then shows you a search page:

5. MedDRA Coding to SOC Level for AE Logs
The page allows you to set the version of MedDRA you are going to use.
For new studies, set this to the latest version (highest number) available.

6. MedDRA Coding to SOC Level for AE Logs
When you return to MedDRA to code AEs later on, you MUST remember to re-set this to the version you started using for that particular study.

7. MedDRA Coding to SOC Level for AE Logs
The search page also shows you a list of SOCs:

8. MedDRA Coding to SOC Level for AE Logs
…and allows you to enter key words or phrases (from your AE) to search for here:

9. MedDRA Coding to SOC Level for AE Logs
Type in key words from your AE. For example, here we have inserted headache.
Note that MedDRA offers us some refined terms (‘headache fever’, ‘headache fever flu’) but if they are not relevant to your AE, you can still just enter ‘headache’.

10. MedDRA Coding to SOC Level for AE Logs
Make sure all the search options are ticked as shown below, then click on ‘search’, or press ‘enter’ on your keyboard. After a second or so, the search results will appear.
(NB: Sometimes part-words or partial phrases yield more results in MedDRA than
the entire keyword or phrase.)

11. MedDRA Coding to SOC Level for AE Logs
In this example you have one exact match, plus 74 other results that contain the word ‘headache’

12. MedDRA Coding to SOC Level for AE Logs
These result terms are called “LLTs” (Lowest Level Terms). As you have an exactly matching LLT, click on the little ‘+’ sign next to it.

13. MedDRA Coding to SOC Level for AE Logs
This expands the result to ever-higher level terms (keep clicking the plus signs that appear) until you eventually reach the SOC.

14. MedDRA Coding to SOC Level for AE Logs
There may be more than one SOC (we’ll deal with that in a minute). The primary SOC has a blue border to it (as seen below). The primary SOC is the one you want to enter into the AE log – in this case ‘Nervous System Disorders’.

15. MedDRA Coding to SOC Level for AE Logs
Look up the SOC in the ACCORD MedDRA SOC list supplied with the AE log. ‘Nervous System Disorders’ is number 17.

16. MedDRA Coding to SOC Level for AE Logs
Enter the number for ‘Nervous System Disorders’ (17) into the relevant section of the AE log:

17. MedDRA Coding to SOC Level for AE Logs
Don’t forget to also add the version of MedDRA you used:

18. MedDRA Coding to SOC Level for AE Logs
As we said, there may be more than one SOC arising from your search. For example, entering ‘Chest Pain’ into the search box reveals an exact match:

19. MedDRA Coding to SOC Level for AE Logs
When we expand that all the way to the SOC, we see there are three ‘branches’ that all end in different SOCs:

20. MedDRA Coding to SOC Level for AE Logs
But only the blue-bordered SOC (‘General Disorders and Administration Site Conditions) is the primary SOC, and that is the one that should be entered into the AE log:

21. MedDRA Coding to SOC Level for AE Logs
Again, look up the SOC in the ACCORD MedDRA SOC list supplied with the AE log. ‘General Disorders and Administration Site Conditions’ is number 8.

22. MedDRA Coding to SOC Level for AE Logs
And again, you should log that number for the primary SOC, and the MedDRA version used, in the AE log.

23. MedDRA Coding to SOC Level for AE Logs
Sometimes a search term will not give you any exact matches. In that case, you will need to look at the results under ‘lexical variants’, synonyms or simply those results that ‘contains search results’.
For example, when we searched for ‘Carcinoid’ here, we got no exact matches, lexical variants or synonyms, but we did get 56 results that contained the search word:

24. MedDRA Coding to SOC Level for AE Logs
When we click on the ‘+’ sign to expand the 56 results, we get a lot of possible LLTs to choose. You should follow the LLT that is closest to the AE description you are working with. If you cannot decide between two or three LLTs, click through the ‘+’ signs for each of them until you get to their SOCs – you will probably find that the SOC turns out to be the same one in each case!
Notice that some of the LLTs are marked with a red border. These are ‘non-current’ LLTs and should not be used/followed.

25. MedDRA Coding to SOC Level for AE Logs
Once you have completed your search and entered the SOC number into the AE log, you can clear your search from MedDRA by clicking on ‘Clear Search’. Then you can continue to search for other terms if you need to.

26. MedDRA Coding to SOC Level for AE Logs
Hopefully this short presentation will help you work with MedDRA without any major issues.
If you DO encounter any problems, you can contact the Pharmacovigilance team in ACCORD via ( ).
Thank you for your attention.