Attachment 12 (Cover Letters)

OMB Number: 0925-0407

Expiration Date: 10/2008

Sample Cover Letter to Request Medical Records

(Date)

(Name of Institution)

(Address of Institution)

(City, State, Zip Code)

RE: (Name of Participant) Date of Birth: (Participant DOB)

Date of PLCO Visit: (Date of Visit)

Dear (Head of Medical Records Department):

The above named is a participant in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, and has indicated that he was intending to be seen at your institution for follow-up of abnormal screening examinations done by PLCO.

In order to complete our records, we would appreciate receiving copies of medical records after the date of the PLCO visit to the present for visits pertaining to an abnormal (Type of Exam) done by our study. Enclosed you will find a copy of the consent form authorizing release of information. Please send the following information in regards to any (Type of Exam) done after (Date of PLCO exam).

___ Progress notes for follow-up visit ___ Lab report (PSA)

___ Operative report ___ Pathology report

___ Radiology report ___ Treatment record

If you have no records for this patient, please check here (__ we have no records) and return this letter.

Thank you for the time and effort involved in complying with our request. If you have any questions, please do not hesitate to call (Coordinator Name) at (Telephone Number).

Sincerely yours,

(Name of Investigator)

Principal Investigator

Sample Cover Letter for Annual Study Update & Follow-up Locator Form

(Date)

(Participant Name And Address)

Dear (Participant Name),

Thank you for your continued participation in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. As you may recall, once a year we will be asking you for information about your medical care during the year.

Enclosed are two questionnaires: an Annual Study Update and a Follow-up Locator Form. The Annual Study Update asks about your recent medical care and the Follow-up Locator Form asks for identifying information, such as your address, phone number, doctor’s name, etc. Please take a few moments to complete these questionnaires and return them in the postage-paid envelope provided.

If you are unable to complete these forms, please contact the Screening Center or have a member of your household contact the Screening Center to advise us of your situation.

Please be assured that all information you give will be kept confidential and will not be disclosed to anyone but the researchers conducting this study, except otherwise allowed by law.

Again, we thank you for your cooperation. Your participation represents a valuable contribution to the outcome of the study, and ultimately may help reduce the number of deaths each year from cancer.

If you have any questions about these forms or about any aspect of the PLCO trial, please do not hesitate to contact me or (Coordinator Name) at (Telephone Number).

Sincerely yours,

(Name Of Investigator)

Principal Investigator

Sample Cover Letter for Health Status Questionnaire

(Date)

(Participant Name And Address)

Dear (Participant Name),

We at the (Screening Center Name) want to thank you for your continued commitment to the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO). The health information you have provided us in the past has contributed to the success of this important national study.

Your ongoing participation is very important. Once again, we would like you to provide us with some valuable information. Please take a few minutes to complete the enclosed Health Status Questionnaire and return it to us in the envelope provided for your convenience. No postage is required. If you are unsure of how to best answer the questions or whether you have had a particular exam, please call your physician’s office or health care provider. Typically, this information can be given to you over the phone in a matter of minutes.

Please remember, all information you give us will be kept confidential, and will not be disclosed to anyone but the researchers conducting this study, except as otherwise required by law. Your name or other identifying information will not appear in any report of the study.

If you have any questions about this form, please contact (Name Of Staff Member), (Title), at (Site Phone Number). Thank you for your time in completing the questionnaire. We look forward to your prompt reply.

Sincerely,

(Name of Investigator)

Principal Investigator