Frequently Asked Questions - Data Exchange Process

1. How should I sent you the data to be coded?

Data to be coded should be sent to us as tab-delimited ASCII text files, Excel spreadsheets, or as SAS datasets, with a separate file for each dictionary to which the terms are to-be-coded.

The format of the files should be one reported term per line/row/observation.

Accompanying each file should be the name of the dictionary and version to which the terms should be coded.

Return to top

2. Do I need to remove duplicate terms?

You do not need to remove duplicate terms when you send us data to be coded. Our thesaurus system will automatically remove duplicate terms to generate a list of unique terms.

Return to top

3. Do I include patient information when I send you the data?

We generally ask that patient information not be sent to us due to the sensitivity of transferring patient data across the internet. All coding is done out of context, so patient data is not used and/or needed.

Return to top

4. Do I need to keep track of what data I already sent you?

You do not need to keep track of what data you already sent us. Data can be sent to us incrementally (only new terms collected since the last dataset was sent) or cumulatively (all terms collected to-date for a study, project, etc.).  If you send us cumulative data, our thesaurus system will automatically determine which terms have not yet been coded. Our recommendation therefore is to send data cumulatively as it avoids the need for you to keep track of what data has already been sent.

Return to top

5. How will the coded data be sent back to me?

A file will be created for each dictionary to which terms have been coded. Each line/row of the file will contain one reported term with as much of the dictionary hierarchy as you desire. We can return the file of coded data to you as a tab-delimited ASCII text file, Excel spreadsheet, or SAS dataset.

Return to top

6. How do you handle terms that cannot be coded?

For each dictionary, an additional Excel spreadsheet will be returned to you for any terms that were unable to be coded.  Each line/row of this file will contain one reported term along with the reason the term cannot be coded and/or a query requesting clarification.

Click here for more information about terms that cannot be coded.

Return to top

7. Do the queried terms have to be in a separate file? Or can they be combined into a single file with the coded data?

Queried terms can be combined into the same file as the coded data. Each reported term in the file will either have coding information or will have a query associated with it.

Return to top

8. I have a specific format (layout) in which I would like the receive the coded data. Can you accommodate a client-specific layout?

Yes, we can accommodate any layout you need. Our thesaurus system has a facility that allows us to create and maintain layouts specific to you. For example, you can have a layout for MedDRA-coded data and a different layout for WHO Drug-coded data.

Return to top

9. How is the data protected during transfers?

Return to top

10. Why do you use the tab character as the delimiter?  Can you use comma-separated files or some other character instead of a tab?

We use the tab character for two reasons: (1) because tab-delimited files can be easily used by programs such as SAS, Excel, Oracle, etc.; and (2) because the tab character never appears within the data itself.

Commas frequently appear in the reported terms as well as within the coding information from the dictionaries. Text containing a comma therefore needs to be double-quoted to signify that the comma is a literal part of the text and not a delimiter. The addition of these double quotes tends to create problems when trying to read the file into other programs because the double quote characters are not then always stripped off properly by the receiving program. In other words, it is necessary to ascertain whether the double quote characters found in a comma-separated file were part of the original text or were introduced to "protect" a literal comma within the text.

Likewise, characters such as '$' or '|' are problematic as delimiters because they can and do appear within the text of the coded data.

Return to top

11. Can my CROs send and receive data directly?

Yes, your CROs can send and receive data directly. While most of our clients that are sponsor companies prefer to be a single point of contact for their CROs, we can and do work directly with their CROs.

Return to top

12. How often can I send you data to be coded?

Click here to see the answer to this question in our Services FAQ.

Return to top

13. How frequently can I receive back the coded data?

Click here to see the answer to this question in our Services FAQ.

Return to top

14. What levels of the dictionary will I get back with the coded data?

You will get back as much or as little of each dictionary as you want.

Click here for more information about the levels we return with MedDRA-coded data.

Click here for more information about the information we return with WHO Drug-coded data.

Return to top

15. When I submit terms for coding, can I ask for a certain set of them to be coded first?

Yes. The easiest method is to create a separate file containing the terms that have a higher priority. When you submit your terms for coding, let us know that this separate file needs to be coded first.

When you create the file of priority terms, you do not need to remove those terms from the file containing all of the terms. When we load in the file containing all terms, our thesaurus system will automatically detect that the priority terms have been coded already. You will not get charged for submitting the priority terms again because we charge on a unique term basis.

Return to top