The following is copied from OAIS v1 (2002) and may be out of date

1 NATIONAL COLLABORATIVE PERINATEL PROJECT (NCPP) 1959-1974

1.1 DOMAIN

Domain and Customers

The National Collaborative Perinatal Project was a multi-institutional, multi-year study of pregnant women and the children born from those pregnancies to provide baseline information useful for later determining the causes of neurological diseases which appeared in a portion of the studied population. The data came from medical histories, examinations, and observations. The records also contain socioeconomic, family history, and family health information. The data are used by a variety of medical and other researchers.

Data Producers

The predecessor to the U.S. National Institutes of Health’s National Institute of Neurological Disorders and Strokes (NINDS) began the National Collaborative Perinatal Project in 1958. Fourteen university-affiliated medical centers across the United States participated in the study. Between 1959 and 1965 each cooperating medical center collected information on between 300 and 2000 pregnancies each year for a total of 55,908 pregnant women utilizing their clinic services. This represented between 14% and 100% of the women utilizing these services depending on the sampling rate employed at each clinic. The final population was reduced to 39,215 due to miscarriages prior to twenty weeks, 445 multiple births, exclusion of subsequent or repeat pregnancies, and deletion of incomplete records due to women withdrawing from the study prior to its completion. The children were given neonatal examinations and follow-up examinations through eight years of age. The last examinations were conducted in 1974. The computer data files resulting from the research that NINDS transferred to the National Archives and Records Administration (NARA) consist of approximately 6,200,000 records organized into a Master File, a variable file, and eighteen work files, one of which consists of thirteen distinct data files.

Special Features

The Collaborative Perinatal Project was a longitudinal multi-disciplinary research effort which sought to relate the events, conditions, and abnormalities of pregnancy, labor, and delivery to the neurological and mental status of the children of these pregnancies and their siblings through eight years of age. The study sought to link any later appearance of cerebral palsy, mental retardation, learning disorders, congenital malfunctions, minimal brain dysfunction, convulsive disorders, visual abnormality, or communicative disorders to patterns during the perinatal period in order to develop strategies for prevention and intervention. The sample population is large enough so that statistically significant numbers of such disorders would appear in the children. Study of the records relating those children could result in the development of predictive factors and possible preventive care or intervention actions which could reduce future incidence rates.

The data are available in two formats; microfilm of the individual case files for the mother and child of approximately 270 pages per case file, and the computer data files. Access to the microfilm and two of the computer data files is restricted because they contain personal identifiers. The National Archives has created a public use file for the Master File and Work File 16: Serum Specimen Inventory.

1.2 INGEST

The ingest process for transferring any federal agency records to NARA begins with the agency identifying the records and assessing their potential evidential, legal or research value. The next step is for the agency to develop a Submission Agreement (Standard Form 115, Request for Records Disposition Authority), and submit it to NARA. NARA staff then appraise the records in terms of their evidential, legal, and informational value and their long-term research potential. NARA and the creator then establish a transfer date, negotiate any restrictions on access, and initiate the ingest process.

Ingest for the NCPP computer data was a two phase process. In Phase One, from 1958 through 1974, NIH’s NINDS funded the project and the cooperating institutions conducted the research. Contractors accumulated the original examination records, created the consolidated case files, microfilmed the records, normalized the data, and developed the Master File, an extract file of frequently used variables, and special files such as ‘refined diagnoses’. The data were stored on 23 reels of magnetic computer tape recorded at 1600 bpi. Prior to 1980 the data were available only to NINDS, the cooperating hospitals, and selected government researchers.

In Phase Two NINDS developed the documentation necessary for more generalized use of the data and negotiated a submission agreement, including access provisions, with NARA. Since the data which could not be released could be made anonymous through creation of a Public Use File, the producer and NARA worked on transferring the data files first.

Submission Agreements

NARA and NIH executed the U.S. Government’s standard transfer form, Standard Form 258, Request to Transfer, Approval, and Receipt of Records to the National Archives of the United States, in mid-1985. This transferred legal custody and preservation responsibility to NARA. A similar agreement for the microfilm examination records was executed in 1990 after NARA and NIH resolved the privacy and access concerns and NARA developed a statistical research form.

Delivery Session

The delivery session was a single transaction in which NIH provided NARA with copies of the 23 reels of magnetic tape containing the NCPP and the related documentation consisting of seven volumes containing the background of the study, the sample, data collection and data processing overviews, record layouts and coding for each variable, sample forms, and a bibliography of all published research through 1985. NINDS transferred the 8000 rolls of microfilm containing the examination records in 1990.

Transformation Process

NARA has maintained and preserved the original data format. The data are in a hardware and software independent EBCDIC format which facilitates wide researcher access. All data were copied to new nine-track open-reel magnetic tape when received in 1985 and are migrated to new media every ten years to ensure Long Term Preservation. The more than 7000 pages of documentation are available in both a page format and in a microfiche format on 75 fiche. The documentation has not been scanned or digitized.

Validation

Validation was performed as part of quality control throughout the life of the NCPP. Extensive use of the data during the life of the project (1958-1974) and its use by NIH approved researchers (1958-1985) provided a second de facto validation. NARA also validated sample portions of the data at the time of ingest. Continuing researcher use also validates the data contents.

Security

The computer data is maintained in environmentally-controlled closed stacks which are accessible only to NARA staff. Master and backup copies of the data are stored in separate vaults in separate locations to facilitate disaster recovery. NARA has created Public Use Files of the restricted data files to prevent unauthorized access to personal and medical data.

What Descriptive Information is Provided?

NARA has prepared multiple levels of descriptive information for the NCPP. These range from entries for each data file in the Electronic and Special Media Records Services Division Title List, an abstract entry for the series, a series description, a full documentation package, to a series-level entry in the three-volume Guide to Federal Records in the National Archives.

What Validation Objects are Provided?

During its active life the NCPP established and used elaborate data collection, input and verification procedures. Extensive use also validates the information. NARA’s routine transfer and storage procedures also validated the data. The extensive seven-volume documentation includes record layouts and codes, methodology statements, data analyses, and a bibliography of research use.

What Transformation Processes are Performed Prior to Storage?

What Metadata is Created? NARA staff supplemented the documentation with an abstract and introduction discussing the origin, creation, and uses of the data, including an explanation of restrictions on access and the characteristics of the Public Use File.

What Validation is Performed? NARA’s accessioning and storage procedures included creating a new master and backup copy on new certified magnetic media and creating a Public Use File of the two restricted data files. Sample portions of each data set also were verified against the documentation.

1.3 INTERNAL FORMS

Storage. NARA maintains separate sets of the master and backup copies of the data and the Public Use Files on newly certified 3480 class magnetic tape cartridges.

Migration (Data). NARA migrated the NCPP from 23 nine-track, 1600 bpi open-reel magnetic tapes it received in 1985 and stored the data on seven nine-track, 6250 bpi open-reel magnetic tape. NARA migrated the data to four 3480 class magnetic cartridge when the media was ten years old.

Migration (Metadata). NCPP metadata is available in textual (7000+ pages) and microfiche (75 fiche) forms. There are no plans to scan or digitize the text.

Migration (Format). The data currently are encoded in EBCDIC with all extraneous characters removed. There are no plans to migrate the format at this time.

1.4 ACCESS

What Finding Aids are Provided?

Information (of varying detail) about the NCPP is available in the 1996 three volume Guide to Federal Records in the National Archives of the United States, where the records are described in the context of the larger holdings of the National Institutes of Health; in Information About the Electronic Records in the National Archives for Perspective Researchers, General Information Leaflet 37; in Title List: A Preliminary ad Partial Listing of Data Files in the National Archives and Records Administration; and in the documentation package for NCPP. Much of this information is available on the Division’s homepage (http://www.nara.gov/nara/electronic) or by posting an enquiry to the Division’s e-mail site (cer@nara.gov).

Security

NCPP, like all of NARA’s holdings, is maintained in environmentally-controlled closed stacks which are accessible only by authorized staff. Master and backup copies of the data are stored in separate vaults in separate locations to facilitate disaster recovery. Researchers do not have direct access to the data. Presently they acquire copies of the data on a cost-recovery basis permitting indefinite use of the data for their own purposes.

Customer Service/Support

The Division has a staff dedicated to providing reference services to the public and to the staffs of other federal agencies. The reference staff responds to inquiries by telephone, mail correspondence, e-mail, or in-person visits. They fill orders for copies of all or part NCPP and the relevant documentation. The staff also function as a filter between researchers and the NINDS when problems develop in understanding or interpreting the data.

Do You Support Event Based Orders?

NARA’s Trust Fund is willing to establish accounts that allow researchers to acquire data that is transferred on a recurring basis. Since the NCPP stopped collection data in 1974 there is no need for a subscription for this data.

What Media/Format do you use?

Copies of the 32 data sets comprising the NCPP are available on seven nine-track open-reel magnetic tapes, six 3480 class magnetic tape cartridges, or two CD-ROM.

What Transformation (Value Added) is Provided?

The NCPP is provided as received from NINDS. NARA has created Public Use Files for the two data files containing personal identifiers in conformance with the Freedom of Information Act and NARA restrictions on access to records whose release might result in unwarranted invasion of personal privacy.

Pricing Policies

Electronic data sets are available on a cost-recovery fee schedule developed by the National Archives Trust Fund. Currently the charge for an exact copy of all NCPP data on a storage reel or 3480 class cartridge is $80.75 when copied to a 3480 class magnetic tape cartridge and $90.00 when copied to a nine-track open-reel magnetic tape. Copies on CD-ROM are $90.00 for the first file and $24.50 for each additional file written to the CD-ROM. Paper reproductions cost $10.00 for the first 20 pages and $5.00 for each additional block of 20 pages. Microfiche reproductions cost $2.10 per fiche.

1.5 SPECIAL CHARACTERISTICS

The National Collaborative Perinatal Project was a prospective study. NINDS expended more than $200 million over two decades to collect information on more than 58,000 pregnant women and their children at fourteen cooperating institutions. It is unlikely that a study of this duration and magnitude will be repeated. The data continue to constitute an important resource for biomedical and behavioral research in many areas of obstetrics, perinatalogy, pediatrics, developmental psychology and other fields.