P.R. Laws tit. 24, § 392
(a) The Registry shall establish the data elements it deems necessary to guarantee compliance with its duties and responsibilities as set forth herein, as well as with federal and Commonwealth regulatory agency requirements. Said elements shall also be established to conduct epidemiologic studies aimed at researching the presence and effect of risk factors related to cancer.
(b) The Registry shall gather the following information from medical and other documents for each case of in situ or invasive cancer or benign or malignant tumors of the central nervous system:
(1) Demographic data on the age, ethnicity, and sex of the cancer patient.
(2) Data on clinical history.
(3) Administrative information, including date of diagnosis and data source.
(4) Diagnostic data and related studies.
(5) Data on the characteristic pathology of such cancer, including its location, stage, and extent.
(6) Specific data on treatment.
(7) Follow-up data.
(8) Any other information required by the Registry for statistical purposes only.
(c) Case reports shall be sent in electronic format using programs designed for reporting cancer cases which have been supplied or approved by the Registry. Likewise, entities required to report shall send such data through the means and in the medium and format that the Registry deems more appropriate to guarantee the confidentiality, safety, and integrity thereof.
(d) The Registry shall be in charge of evaluating and training the personnel designated by the entity for case reporting, and shall certify the person when he/she is qualified for reporting thereto. It shall be the responsibility of the reporting entity to designate persons with the minimum necessary qualifications, as established through regulations, to be trained for this task.
(e) The Registry shall establish the methods, criteria, and additional requirements to ensure the optimum quality of the data through training, certification, evaluation, and any other methods it deems necessary therefor.
History —July 30, 2010, No. 113, art. 5, §§ 1–5.