What Source Means

Part of Research Assistant (ASSIST) Training: Writing It Down So It Can Be Relied On.

About 1 minutes. Free, in your language, no account needed.

Source is wherever it was written first

The source is the original record of something happening: the clinic note, the printout from the machine, the page you wrote the time on. Everything else is a copy of it.

This matters because a monitor checks the data in the study database against the source. If they do not match, the source wins, and the difference has to be explained.

You may be creating source without realizing

If you write a time on a worksheet and that is the only place it exists, you have made a source record. It needs a date, your initials, and no gaps.

Scraps of paper are the classic trap. A time noted on a sticky note and copied over later means the source was the sticky note, and it has been thrown away. Use the worksheet, or whatever your site uses, from the start.

Do not write it twice

If a value exists in the hospital record, it usually does not need copying into a second place. Every extra copy is another chance for the copies to disagree, and a monitor then has to work out which one is true.

Your site will have decided where each thing lives. Ask, rather than helpfully duplicating.

Printouts count

A strip from an ECG machine or a label from a set of scales is source. It gets kept, labeled with the participant number and date, and filed where your site keeps it.

Do not throw one away because you have written the number down. The printout is the original; your transcription is the copy.