R1 - Introductory Letter

Form Approved
OMB No. 0920-0010
Exp. Date: XX/XX/20XX
BD-STEPS– Protocol #2087
Introductory Letter (English), 10/7/2014

April 24, 2015
«motherfirstname» «motherlastname»
«Address1»
«Address2»
«City», «State» «Zip»
Dear Ms. «motherlastname»:
We invite you to participate in the Birth Defects Study To Evaluate Pregnancy exposureS (BD‐STEPS). In ,
this study is being conducted by < or >. It is funded by the Centers for Disease Control and Prevention.
The study will help us understand why one out of every 33 babies is born with a birth defect. We plan to speak with
women who had pregnancies affected by birth defects as well as women whose babies did not have birth defects.
State laws give the permission to review medical records to study
causes of birth defects. This is how we identified most women for the study. Women whose babies do not have
birth defects were selected randomly from women who gave birth in the same year.
Our interviewers will call you soon to ask you to do a telephone interview that takes about 45 minutes. The
interview can be done in one call or in several shorter calls at a time that is convenient for you. We are here
< Monday through Thursday 9 am –midnight, Friday 9 am - 9 pm, Saturday 9:30 am - 6 pm, Sunday 1 pm - 9:30 pm
EST. adjust times for appropriate time zone>. The interview asks about your health, medication use, and lifestyle
during your recent pregnancy and the month before your pregnancy. We will keep any identifying information that
you provide during your interview confidential.
<. The bloodspot samples will
allow us to study genetic (inherited) factors that may contribute to the causes of birth defects. If you do not
want us to request a leftover bloodspot, we would still like you to do the telephone interview. >>
Our interviewers will call you within the next two weeks. Before then, if you have any questions, please feel free to
call the interviewers at our toll free number, 1-888-743-7324, or email them at [email protected]. You may
also call me at < insert local contact number>. If you do not want to participate, please let us know.
We’ve enclosed a $20 gift card as a token of appreciation for your time and interest. This is yours to keep whether or
not you do the interview.
Thousands of women across the country are taking part in this important research. This study will help us better
understand the causes of birth defects. We hope that you will be a part of this effort. Thank you for considering this
request.
Sincerely,
< Insert PI name and local contact information >
Enclosures