Len,
The FDA has loads of information on this subject.  As I recall, they
have "investigator bulletins" which address research records.  Try
FDA's Regulatory Affairs office.  There are specific guidelines
along the lines of what FDA prescribes as "good laboratory practices".
A phone number is 301-443-1500.  Sometimes sponsoring drug companies
include such guidelines with the protocol.
Garry Sanders, University at Albany