Source Documents

[gsi00154]

I am confused about Source Documents. After reading a protocol I am in the process of making a day to day order sheet for each visit. Basically to help me with what I must do at each visit. Is this a source document? Or are only info off the medical record consider source documents? Also as far as SOPs. Are there standard documents you should have before study start up? SOP on informed consent, shipping specimens, traing staff etc what are the standard ones you should have.

Thanks

[flyingchange]

I am confused about Source Documents. After reading a protocol I am in the process of making a day to day order sheet for each visit. Basically to help me with what I must do at each visit. Is this a source document?

Yes, these are called Case Report Forms, and they are for officially documenting the data to be tracked at each visit: bloodwork, vitals, that kind of thing. We consider CRFs the actual study documentation (what actually gets put into the database for analyzing results) and we consider your medical record info (x-rays, CT, etc) to be supporting documentation.

Also as far as SOPs. Are there standard documents you should have before study start up? SOP on informed consent, shipping specimens, traing staff etc what are the standard ones you should have.

Yes you should have SOPs in place at the very outset of a study. We have one set of SOPs for our group, not for each study. Off the top of my head, the most critical are informed consent and protecting patient information.