Crosswalk of Protocol Changes

Appendix K: Crosswalk Table for Protocol Modifications
Per- or Polyfluoroalkyl Substances Exposure Assessments (PFAS EAs)
OMB #0923-0059
Revision
Methodology	Exisiting Methodology	Lesson Learned from the 8 EAs	Revision to protocol
Recruitment Strategy	A responsivity rate of 65% was assumed in response to the invitation letters.	The response rate used in the original protocol was not verified during the EA process. The average response rate across the 8 EA sites was 10% for the recruitment letters and not a rate of 65% cited in the protocol.	A response rate of 10% for the recruitment letters will be used for additional EAs. A maximum of 3000 recruitment letters will be sent in each community.
	Recruitment was based on recruitment letters and phone calls	Given the low response rate resulting from the letter recruitment, door-to-door recruitment may be an option to provide a higher rate of response.	Include door-to-door recruitment as an option for recruitment, as needed.
Administation of Questionnaire	Questionnaires were only administered in person	Based on modifications made in response to COVID-19 protocols, the addition of administering questionnaires by phone should be made.	Administration of questionnaires via phone will be added as an option to the protoocl.
Questionnaire	Questions regarding water intake and the use of treatment systems before PFAS was mitigated in the water were not included.	During the data analysis, questions regarding water use and treatment systems in place before the PFAS in water was mitigated would have been helpful.	Additional questions regarding water intake and treatment systems used prior to mitigation will be included in the questionnaire.
Data Management Plan (DMP) (Appendix I)	DMP included in protocol	Additional requirements were included in the DMP appendix	Additional requirements were included in the DMP appendix: 1. NCEH/ATSDR Data Use Agreement Template (Appendix I2). 2. Standard Operating Procedures (SOPs) for Data Management (Appendix I3)