• Project Development Summary
• Project Request Form

Involvement from Concept to Presentation Planning and Grants Submission Pre-study set-up (pre-initiation) Study Conduct Results and Data Analyses Presentations and Publications Study Closure Investigator Options Project Driven Electronic Management with back-up

Online Project Request Form

Involvement from Concept to Presentation

The knowledge base and skills found at the PRC allow registered PRC investigators to involve the PRC faculty and staff from the hypothesis of a project to the final presentation of a project's findings. Registered investigators submit proposals through the PRC registered PI site domain. PRC staff receive this proposal and a meeting is scheduled to begin assessment of the project's goals, potential funding sources, and dedicated facilities and personnel available for support.

Planning and Grants Submission

PRC faculty and staff can assist in researching the grant information required:

• identifying grant sources
• developing translational, theoretical and analytical concepts
• offering statistical and protocol design support
• providing documentation of validated methods, facilities, biosketches, letters of support
• projecting and budgeting project costs
• drafting proposal, methods, analyses sections
• on-line or other types of grant submission

Once a project is funded, it will move through its life-cycle in several phases: pre-initiation, initiation, conduct, reporting, closure and archival. Quality assurance is ongoing throughout all processes.

Pre-study set-up (pre-initiation)

During pre-initiation, the PRC may:

• develop and validate the analytical method(s)
  The method of analysis identified is tailored for the standardization and sensitivity required by the study
• prepare study forms, kits, and instructions
  Study is assigned a PRC code which uniquely identifies all information throughout the study to the PRC staff. Clinical study conduct details for specimen data collection, specimen collection, specimen processing and storage, specimen labeling, and specimen shipments are designed. The forms and instructions are prepared to assure that the samples and sample information received by the PRC CAL for analysis will be of the best integrity, HIPAA compliant, suitable for analysis and uniquely identifiable.
• create a study specific data base
  The database is designed so that the investigator receives the final data files with the specific identifiers s/he requires for data analysis. Databases vary from simple excel or access forms to highly sophisticated large databases dependent on the need of the project

Correspondence between the investigator and clinical research unit(s) and/or the PRC are required during this phase to accurately and specifically prepare the IRB submissions, study sample forms and create the necessary corresponding fields in the study database.

Study Conduct

Once a project is initiated, the PRC staff will work with the investigator and/or clinical site(s) to maintain study contracts with sponsored programs, maintain and submit IRB documents, receive and analyze the samples, communicate ongoing biometric analyses and results and provide reports as needed. Billing will occur as agreed upon with the project investigator.

Results and Data Analyses

Laboratory Results ( PRC CAL ) : At the completion of the analytical project, an analytical report is issued. The report contains the raw data results, an overview of the project conduct at the PRC CAL and standardization and quality control summaries. Manuscript sections for methods can also be provided as needed. In the event that a new analytical method was developed for the project, the PRC CAL will prepare a method manuscript for submission to an appropriate journal; co-authorship of PRC CAL is required.

Biometric Results: Study data and outcomes data are reviewed with the investigator prior to performing the pre-proposed project analyses. If the proposed analyses are suitable for the outcomes data, the biometric analyses will proceed. Otherwise, the investigator and the biometry faculty will discuss and decide on a suitable alternative analysis.

Presentations and Publications

Results Presentation: Investigators are encouraged to present their preliminary findings to the PRC informally and discuss their conclusions.

Formal Presentations and Publications: The PRC faculty and staff are experienced with poster design, powerpoint presentions, and publication submissions. Mentoring and assistance to new investigators is available.

Study Closure

During project closure, samples are moved to long-term storage or shipped back to the investigator. The shipment records, analytical records and other records are moved to archival for storage. The database and other electronic records are archived to electronic storage media and stored.

Samples and records are kept in archival for at least five years and are only discarded with investigator approval.

Investigator Options

Some investigators may not require all the assistance that the PRC provides. Investigators may also require elements that are not standard to the PRC operations. In either case, the PRC will strive to provide the elements of service that the investigator requires. When additional elements are required the PRC will investigate the feasibility of meeting the investigator's needs.

Previous examples of meeting investigator specific needs are:

• Obtaining Certificate of Confidentiality from NIH
• Training of students, post-docs and fellows
• NYDOH certification for a method
• Creation of interactive laboratory specific website
• Active involvement on study specific conference calls or attendance to off-site meetings
• Development of multi-analyte assays
• Preparation and shipping of sample collection kits

Project Driven

PRC activities are driven by the projects that they are conducting. As such, the availability of support are subject to change. Thus, the PRC requires that the time and resources be planned ahead. In addition, the prior dedication of the resources to earlier contracted work may sometimes necessitate that a waiting period occurs.

Electronic Management with back-up

PRC data management strives to ensure that all transcriptions of data are electronic whenever feasible. The PRC has its own secure server system(s) that are copied nightly for data rescue purposes. In the laboratory, all chromatography equipment is managed by electronic acquisition stations driven by manufacturer specific software. The same software packages allow for the collection of the method analysis data, calibration and calculation of results. Results are electronically exported to excel data files and imported into the access databases. ALL MANUALLY transcribed data are checked for accuracy by 100% audit of the entry. A peer review process is utilized to verify the data entry accuracy.