We know the temptation to pick up an old study’s documents and try to revise them to fit a new study is great. We also fervently hope you resist it each and every time you face it.
Here are ALL of the reasons to NOT try to adapt an old document to a new study. There are only two. But they’re both really good reasons.
–Some of the material from your old study will inevitably be included in your new study, and it will be wrong and need to be corrected. How do we know this? Because we are constantly sending back contingencies to investigators having them fix such errors. We have seen someone try to adapt a heavy duty clinical trial consent form to a relatively simple behavioral study. We have seen statistical analysis sections that talk about an entirely different disease of interest than the entire rest of the protocol does.
–The template you used to create that previous study document will not comply with current requirements. How do we know this? Because in the less than 2 weeks since we posted the most recent plain language consent template, we’ve noticed (or had pointed out to us) two errors (correction: now three errors) in it, requiring a new one to be posted each time.
So, every time you think you’re saving yourself some work by editing old documents into new studies, please remember that you’re really not. You’re instead setting yourself up to have to fix stuff and slow down your new study approval.