Each protocol must specify—
(a)
The data to be gathered;
(b)
The sources of the data;
(c)
The activities and steps to be followed in collecting the data to promote its accuracy, validity, and reliability;
(d)
The proposed method or methods for validly analyzing and interpreting the data once obtained; and
(e)
Instructions, guidelines, worksheets, and other documents or tools necessary for implementing the protocol.