Form 2 Initial Data Collection Form

Data Collection Form OMB No.: 0925-XXXX

7/29/2014 Expiration Date: xx/xx/20xx

OMB No.: 0925-XXXX

Expiration Date: xx/xx/20xx

Collection of this information is authorized by The Public Health Service Act, Section 411 (42 USC 285a). Rights of study participants are protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing from the study at any time. Refusal to participate will not affect your benefits in any way. The information collected in this study will be kept private to the extent provided by law. Names and other identifiers will not appear in any report of the study. Information provided will be combined for all study participants and reported as summaries. You are being contacted by email to complete this instrument so that we can develop a database and keep the website up to date.

Public reporting burden for this collection of information is estimated to average 90 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-XXXX). Do not return the completed form to this address.

Thank you for taking the time to complete this form. The information you provide will populate the Cancer Epidemiology Descriptive Cohort Database (give URL). Users of the CEDCD will be able to find information about Cancer Epidemiology Cohorts such as yours in a single unified database. The CEDCD will enable users to learn about existing cohorts, compare cohort characteristics, and tabulate counts of participants, cancers, and specimens across cohorts. We hope you will find the CEDCD useful in seeking collaborators and facilitating projects.

This form is pre-filled with as much information as was possible to locate from available sources. Please review for accuracy and add information as needed.

Please return this form to Westat (cedcdhelpdesk@westat.com). The information on this form will be electronically loaded to the CEDCD database through an automated process. Annual updates are planned to ensure that the database reflects accurate up-to-date information about your cohort.

Basic Cohort Information (If your cohort is comprised of more than one distinct enrollment period (such as Physicians Health Study I and II), please complete separate Cohorts Descriptive Database Collection Forms to treat them as separate cohorts.)
A.1a Cohort Name:
A.1b Cohort Abbreviation:
A.1c Cohort Website: (if available)
A.2 Date Form Completed:				_______________________ MM / DD / YYYY
A.3 Person whom completed the form:									Contact Person for clarification of this form:
Name: Position on the cohort: Phone: Email: Is this the person to contact with questions about this form?		No Yes If no, please provide the name and contact information for correct person in the space on the right.							Name: Position on the cohort: Phone: Email:
A.4 Cohort’s Principal Investigator(s) and Co-Investigators: If there is not enough room below to list all of the investigators, please attach a separate document listing all of the investigators with all the information specified below. Please provide title at your home institution.
Name: Title: Institution: Phone: Email:								Name: Title: Institution: Phone: Email:
Name: Title: Institution: Phone: Email:								Name: Title: Institution: Phone: Email:
Basic Cohort Information (continued)
A.5 If an investigator is interested in collaborating with your cohort on a new project, whom should they contact?
Name: Position on the cohort: Phone: Email:
A.6 Cohort Description: Please provide a short paragraph describing your cohort. This will be used as an overall narrative description of your cohort on your cohort’s page on the CEDCD website.
Basic Cohort Information (continued)
A.7 Cohort Design:							Check one: Risk Cohort – (initially enrolled participants without cancer) Survivor Cohort – (initially enrolled participants with cancer) Lifecycle Cohort – (multi-generational enrollment within families)
A.8 Is the cohort a survivor cohort built from a previously established risk cohort?					No Yes		If yes, Were data collected before enrollment into the survivor cohort? No Yes Were biospecimens collected before enrollment into the survivor cohort? No Yes Please complete the remainder of this form as it pertains only to data and specimens collected from establishment of the survivor cohort; do not include data and specimens collected as part of the previously established cohort.
A.9 Is this a multi-site cohort? No Yes If yes, please list the participating institutions and investigators:
a. Investigator: ______________________________ b. Investigator: ______________________________ c. Investigator: ______________________________ d. Investigator: ______________________________ e. Investigator: ______________________________ f. Investigator: ______________________________ g. Investigator: ______________________________ h. Investigator: ______________________________ i. Investigator: ______________________________ j. Investigator: ______________________________						Institution: ________________________________________ Institution: ________________________________________ Institution: ________________________________________ Institution: ________________________________________ Institution: ________________________________________ Institution: ________________________________________ Institution: ________________________________________ Institution: ________________________________________ Institution: ________________________________________ Institution: ________________________________________

Basic Cohort Information (continued)

A.10 Eligibility Criteria:

Age: Eligible Age Range: ___________ to _____________ Gender: Both genders eligible Males only eligible Females only eligible

A.11 Enrollment:

_________________ to _________________ Year Started (YYYY) Year Ended (YYYY) Check if enrollment is ongoing

A.12 Age at Enrollment (range and median):

Range: ______ To ______ Median: _____________ If your cohort is a lifecycle cohort enrolling multiple generations within families, then specify the age of each generation. First Generation – Age Range: ______ To ______ Second Generation – Age Range: ______ To ______ Third Generation – Age Range: ______ To ______

A.13 Specify time intervals when your questionnaire data were collected. For example, yearly, biannually, 2011-2013.

Specify:

A.14 Most recent year when questionnaire data were collected:

____________ Year (YYYY)

A.15 How was information from the questionnaire administered/collected?

Check all that apply: In person Paper Electronic / Web-based Other, specify: ________________________________________________ ________________________________________________

A.16 Were any tools aside from questionnaires used for exposure data collection? (e.g., an accelerometer for recording physical activity)

No Yes If yes, specify the instruments: ___________________________________________________ ___________________________________________________

A.17 Most recent year of confirmed cancer case ascertainment:

____________ Year (YYYY)

A. Basic Cohort Information (continued)

A.18 Most recent year of mortality follow-up:

____________ Year (YYYY)

A.19 Does your cohort have any known restrictions on participating in collaborative projects involving pooling of data or specimens or use of specimens in genomic studies? (For example, restrictions due to the wording of the informed consent?)

No Yes If Yes, please describe briefly: _______________________________________________ _______________________________________________

Current Enrollment Counts

B.1 Total number of subjects enrolled: ________ If still enrolling, please specify the target number you plan to enroll: ___________ If still enrolling, please specify by when do you plan to enroll subjects: _______________________ YYYY

B.2 Number of Males enrolled: ___________

B.3 Number of Females enrolled: ____________

B. 4 Racial Categories

Ethnic Categories

Total

Not Hispanic or Latino

Hispanic or Latino

Unknown/Not Reported Ethnicity

Female

Male

Unknown/ Not Reported

Female

Male

Unknown/ Not Reported

Female

Male

Unknown/ Not Reported

American Indian/ Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

More Than One Race

Unknown or Not Reported

Total

C. Data on Major Content Domains

Specify whether you collected data within these major content domains. Baseline refers to data collected at or near enrollment into the cohort. If a lifecycle cohort, include all exposure data for all generations as follow-up.

Did you collect data on:

Check all that apply

Collected at baseline

Collected during follow-up

C.1 Marital Status

Collected

Collected

C.2 Socio-economic status (e.g., income)

Collected

Collected

C.3 Education Level

Collected

Collected

C.4 Anthropometry (e.g., weight, height, waist circumference, or BMI)

Collected

Collected

C.5 Cigarette smoking

Collected

Collected

C.6 Use of tobacco products other than cigarettes

Collected If collected, specify other tobacco products: Cigars Pipes Chewing tobacco Other, specify: ______________________ ______________________

Collected If collected, specify other tobacco products: Cigars Pipes Chewing tobacco Other, specify: ______________________ ______________________

C.7 Alcohol consumption

Collected

Collected

C.8 Dietary intake

Collected

Collected

C.9 Dietary supplement use

Collected

Collected

C.10 Physical activity

Collected

Collected

C.11 Reproductive history

Collected

Collected

C.12 Quality of life or other psychosocial variables

Collected

Collected

Data on Major Content Domains (continued)

Did you collect data on:

Check all that apply

Collected at baseline

Collected during follow-up

C.13 Prescription medication use (not related to cancer treatment)

Collected

Collected

C.14 Non-prescription medication use (not related to cancer treatment)

Collected

Collected

C.15 Family history of cancer

Collected If collected, was data collected on: First degree relatives only First and second degree relatives All relatives Do you have pedigrees? No Yes

Collected If collected, was data collected on: First degree relatives only First and second degree relatives All relatives Do you have pedigrees? No Yes

C.16 Environmental or occupational exposures (e.g. air contaminants/quality, occupational exposures and history, water source)

Collected

Collected

C.17 Geocoding Information

Collected

Collected

C.18 Non-Cancer Illness: Check all that apply.

Illness

Prevalent Illness

Incident Illness

Diabetes

Collected

Collected

Heart and Vascular Diseases

Collected

Collected

Lung Diseases

Collected

Collected

Digestive and/or Genitourinary Diseases

Collected

Collected

Osteoporosis/Bone related conditions

Collected

Collected

Data on Major Content Domains (continued)

C.18 Non-Cancer Illness: Check all that apply.

Illness

Prevalent Illness

Incident Illness

Neurodegenerative Disorders and/or Mental Illnesses

Collected

Collected

Autoimmune diseases

Collected

Collected

D. Cancer Information: This section is to capture the extent of cancer information that your cohort collects or currently has available. Please limit your response to data that have already been collected or are part of ongoing collection, and not to include planned collection that has yet to begin. Please include in your consideration data that you ascertain from participants or other data sources as well as derived data (e.g. algorithms to differentiate recurrent vs second primary cancer).

D.1 How were your cancer cases ascertained?

Check all that apply: Self-report Tumor registry Medical record review Other, specify: ________________________________________ ________________________________________

D.2 Do you have recurrent cancer diagnosis?

No Yes

D.3 Do you have second primary cancer diagnosis?

No Yes

D.4 Do you have cancer treatment data?

No Yes If no, would it be possible to collect this information from medical records or other sources? No Yes

If yes, specify treatment and data source: Treatment: Check all that apply Surgery Radiation Chemotherapy Hormonal therapy Bone marrow/stem cell transplant Other, specify: ________________________________________ ________________________________________ Data source: Check all that apply Administrative claims data Electronic record Chart abstraction Patient-reported questionnaire Other, specify: ___________________________________________

D. Cancer Information (continued)

D.5 Do you have cancer staging data?

No Yes

D.6 Do you have tumor grade data?

No Yes

D.7 Do you have tumor genetic markers data?

No Yes If yes, please describe: ___________________________________________ ___________________________________________

D.8 Were cancer cases histologically confirmed?

Select only one: All Some None

D.9 Do you have cancer subtyping?

Check all that apply: Histological Molecular

D.10 Do you have information on cancer-related conditions?

No Yes

If yes, check all that apply:

Acute treatment-related toxicity (e.g., diarrhea, nephrotoxicity)

Late effects of treatment (e.g., cardiotoxicity, lymphedema)

Symptoms management (e.g., fatigue, pain, sexual dysfunction)

Other, specify: ______________________________________________________________________________________________ _______________________________________________________________________________________________

D.11 If you did not collect the information requested in D.2 to D.10, are the data available to be retrieved at a later point in time?

No Yes

	E. Mortality
	E.1 How was death confirmed by your cohort?				Check all that apply: National Death Index (NDI) linkage State death certificates Other, specify ________________________________________ ________________________________________
	E.2 Do you have date of death for most subjects?				No Yes
	E.3 Do you have cause of death for most subjects?	No Yes			If yes, is the cause of death coded? No Yes If yes, what type of death code was used? Check all that apply: ICD-9 ICD-10 Other, specify ________________________________________ ________________________________________
	E.4 What is the number of deaths in your cohort as of most recent mortality follow-up?				_______________
F. Data Linkage and Harmonization
F.1 Have you linked your cohort data to any other existing databases (e.g., Center for Medicare and Medicaid Services, Surveillance, Epidemiology and End Results)?			No Yes	If yes, specify:
F.2 Has your cohort participated in any cross-cohort data harmonization projects not limited to NCI?			No Yes	If yes, specify:

G. Specimens Collected
Specify the types of specimens you collected, whether the specimen was collected at baseline, and/or collected at other time points.
Did you collect any of the following specimens:		Collected at baseline						Collected at other time points
G.1 Blood		Collected If collected, types of aliquots (Check all that apply): Serum Buffy Coat Plasma Other Blood Derivative						Collected If collected, types of aliquots (Check all that apply): Serum Buffy Coat Plasma Other Blood Derivative
G.2 Buccal Swab		Collected						Collected
G.3 Saliva		Collected						Collected
G.4 Lymphocytes		Collected						Collected
G.5 Other Specimen types not listed above (e.g., urine, sputum). Do not include tumor tissue. Specify below:
a.		Collected						Collected
b.		Collected						Collected
c.		Collected						Collected
G.6 Did you collect tumor tissue?						No (Skip to question G.10) Yes
G.7 Did you also collect normal tissue?						No Yes
G.8 How were the tumor tissue samples prepared/ stored?						Check all that apply: Formalin Fixed Paraffin Embedded (FFPE) Fresh/Flash Frozen Diagnostic slides Other, specify: _____________________________________________ _____________________________________________
G. Specimens Collected (continued)
G.9 How was the tumor tissue collected? (Include collection of the same tumor at different time points)							Check all that apply: Core Biopsy Fine Needle Aspirations (FNA) Surgery Other, specify: ______________________________________ ______________________________________
G.10 If your cohort does not currently collect tumor blocks, did you collect information on where the blocks are kept/stored?							No Yes
Do you have:							Approximately How Many Participants
G.11 Genotyping Data (SNP)			No Yes
G.12 Sequencing Data – Exome			No Yes
G.13 Sequencing Data – Whole Genome			No Yes
G.14 Epigenetic or metabolic markers			No Yes
G.15 Other “omics” data			No Yes
H. Technology Use
H.1 In your cohort, have you adopted the use of mobile devices (i.e., tablet computers, personal digital assistants, etc.) for the collection and/or measurement of demographic or lifestyle factors, environmental exposures, and/or other types of information?					Yes, please list or describe: _____________________________________________________________________________________________________________________________________________ No, but we are currently considering it or will consider it in our next renewal. No, and we do not have any immediate plans to do so.
H.2 Most studies store all of their study data on local servers that are maintained at their institution. Cloud computing refers to storing data on the internet. Have you adopted the use of cloud-based approaches for the collection, management, or distribution of any of your study data?					Yes, please list or describe: _____________________________________________________________________________________________________________________________________________ No, but we are currently considering it or will consider it in our next renewal. No, and we do not have any immediate plans to do so.
Technology Use (continued)
H.3 If the answers were "No, and we do not have immediate plans to do so" for either of the prior 2 questions, please indicate the possible reasons.					Check all that apply: Limited funding Limited support from department/institution Limited technical infrastructure or support Security concerns Other and/or please describe: _____________________________________________________________________________________________________________________________________________
Additional Items for Inclusion on the CEDCD Website
As indicated on the CEDCD Approval Form, we are requesting the following items for inclusion on the CEDCD website. If you provided approval to post this information, please attach the documents and return them to Westat with this form If they are already available on a publicly accessible website, please just provide the website address.
Document	Attached			Website URL (if document is not attached)
Questionnaires				URL:
Main cohort protocol				URL:
Data sharing policy				URL:
Biospecimen sharing policy				URL:
Publication (authorship) policy				URL:
CEDCD Biospecimen and Cancer Count Information Spreadsheet				Attached Only
Separate List of investigators (if needed)				Attached Only

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Form Version: 2.0