Common use of Completeness Clause in Contracts

Completeness. i. Ensure completeness of case reporting provided to System Agency by conducting the following activities at least monthly: fully reviewing monthly data quality reports and regularly reviewing surveillance systems to identify any inconsistencies or gaps in laboratory reporting. Grantee is encouraged to implement additional methods of evaluating completeness of key source reporting, after first receiving System Agency written approval. ii. Ensure HIV/AIDS case report forms are accurate and complete in accordance with guidance provided in the Texas HIV Surveillance Procedure Manual. iii. Collect reports of HIV and AIDS cases diagnosed and/or treated, which health care providers (e.g., physicians, HIV service providers, etc.) are required to complete under TAC Title 25, Part 1, Chapter 97, Subchapter F, Rule §97.132. iv. Collect reports of pediatric HIV and AIDS cases diagnosed and/or treated, infants born exposed to HIV, and pregnant women living with HIV diagnosed and/or treated, which health care providers (e.g., physicians, HIV service providers, etc.) and laboratories are required to complete under TAC Title 25, Part 1, Chapter 97, Subchapter F, Rule §97.132. Grantee is responsible for collecting the reports within Grantee’s designated Service Area. For each perinatal exposure investigated, Grantee will complete a pediatric case report form (PCRF), along with an updated adult case report form for infant’s mother. v. Collect all required data elements to conduct HIV surveillance follow-up activities, including conducting medical record abstractions within three months of diagnosis for all patients seen in Grantee’s designated Service Area to properly report all HIV and AIDS cases diagnosed and/or treated within Grantee’s designated Service Area. vi. Abstract medical records requested by another jurisdiction in Texas within the timeframes outlined in the HIV Surveillance Manual. vii. Conduct an investigation to verify any reported adult and/or pediatric HIV or AIDS deaths and abstract medical chart when appropriate within Grantee’s designated Service Area. viii. Follow procedures as outlined in Texas HIV Surveillance Procedure Manual to conduct out-of-state record searches. ix. Manage all laboratory reports in TB/HIV/STD Integrated System (THISIS) in accordance with the Texas HIV Surveillance Procedure Manual.

Completeness. i. Ensure completeness of case reporting provided to System Agency by conducting the following activities at least monthly: fully reviewing monthly data quality reports and regularly reviewing surveillance systems to identify any inconsistencies or gaps in laboratory reporting. Grantee is encouraged to implement additional methods of evaluating completeness of key reporting source reporting, after first receiving System Agency written approval. ii. Ensure HIV/AIDS case report forms are accurate and complete in accordance with guidance provided in the Texas HIV Surveillance Procedure Manual. iii. Collect reports of HIV and AIDS cases diagnosed and/or treated, which health care providers (e.g., physicians, HIV service providers, etc.) are required to complete make under TAC Title 25, Part 1, Chapter 97, Subchapter F, Rule §97.132. iv. Collect reports of pediatric HIV and AIDS cases diagnosed and/or treated, infants born exposed to HIV, and pregnant women living with HIV diagnosed and/or treated, which health care providers (e.g., physicians, HIV service providers, etc.) and laboratories are required to complete make under TAC Title 25, Part 1, Chapter 97, Subchapter F, Rule §97.132. Grantee is responsible for collecting the reports within Grantee’s designated Service Area. For each perinatal exposure investigated, Grantee will shall complete a pediatric case report form (PCRF), ) along with an updated adult case report form for infant’s mother. v. Collect all required data elements to conduct HIV surveillance follow-up activities, including conducting medical record abstractions within three months of diagnosis for all patients seen in Grantee’s designated Service Area to properly report all HIV and AIDS cases diagnosed and/or treated within Grantee’s designated Service Area. vi. Abstract Conduct abstraction, the process of collecting and identifying important data required for a secondary use, on medical records requested by another jurisdiction in Texas within the timeframes outlined in the HIV Surveillance Manual. vii. Conduct an investigation to verify any reported adult and/or pediatric HIV or AIDS deaths and abstract medical chart when appropriate within Grantee’s designated Service Area. viii. Follow procedures as outlined in Texas HIV Surveillance Procedure Manual to conduct out-of-state record searches. ix. Manage all laboratory reports in TB/HIV/STD Integrated System (THISIS) in accordance Manual. As needed, maintain an efficient tracking mechanism, either by paper or electronic file, to record outcomes for all laboratory reports received by local site (including all laboratory reports received through Electronic Laboratory Report and all paper laboratory reports received directly from providers or labs). With the use of THISIS and if needed, the use of an efficient tracking mechanism, Grantee should be able to readily produce surveillance site standings at any given time (i.e., number of cases reported for the month, number of medical record abstractions completed, cases with incomplete algorithms, type of cases completed (new), update to AIDS, perinatal exposure, pregnancy update and number of cases pending along with estimated dates of completion). x. In support of molecular HIV surveillance (MHS), Grantee will complete or obtain HIV Testing and Treatment History information from the Texas HIV Surveillance Procedure Manualreporting provider to complete the testing and treatment history data elements on the Adult Case Report Form (ACRF).

Completeness. i. Ensure completeness of case reporting provided to System Agency by conducting the following activities at least monthly: fully reviewing monthly data quality reports and regularly reviewing surveillance systems to identify any inconsistencies or gaps in laboratory reporting. Grantee is encouraged to implement additional methods of evaluating completeness of key reporting source reporting, after first receiving System Agency written approval. ii. Ensure HIV/AIDS case report forms are accurate and complete in accordance with guidance provided in the Texas HIV Surveillance Procedure Manual. iii. Collect reports of HIV and AIDS cases diagnosed and/or treated, treated which health care providers (e.g., physicians, HIV service providers, etc.) are required to complete make under TAC Title 25, Part 1, Chapter 97, Subchapter F, Rule §97.132. iv. Collect reports of pediatric HIV and AIDS cases diagnosed and/or treated, infants born exposed to HIV, and pregnant women living with HIV diagnosed and/or treated, which health care providers (e.g., physicians, HIV service providers, etc.) and laboratories are required to complete make under TAC Title 25, Part 1, Chapter 97, Subchapter F, Rule §97.132. Grantee is responsible for collecting the reports within Grantee’s designated Service Area. For each perinatal exposure investigated, Grantee will complete a pediatric case report form (PCRF), along with an updated adult case report form for infant’s mother. v. Collect all required data elements to conduct HIV surveillance follow-up activities, including conducting medical record abstractions within three months of diagnosis for all patients seen in Grantee’s designated Service Area to properly report all HIV and AIDS cases diagnosed and/or treated within Grantee’s designated Service Area. vi. Abstract medical records requested by another jurisdiction in Texas within the timeframes outlined in the HIV Surveillance Manual. vii. Conduct an investigation to verify any reported adult and/or pediatric HIV or AIDS deaths and abstract medical chart when appropriate within Grantee’s designated Service Area. viii. Follow procedures as outlined in Texas HIV Surveillance Procedure Manual to conduct out-of-state record searches. ix. Manage all laboratory reports in TB/HIV/STD Integrated System (THISIS) in accordance with the Texas HIV Surveillance Procedure Manual.

Completeness. i. Ensure completeness of case reporting provided to System Agency by conducting the following activities at least monthly: fully reviewing monthly data quality reports sent by CO and regularly reviewing surveillance systems to identify any inconsistencies or gaps in laboratory reporting. Grantee is encouraged to implement additional methods of evaluating completeness of key reporting source reporting, after first receiving System Agency written approval. ii. Ensure HIV/AIDS case report forms are accurate and complete in accordance with guidance provided in the Texas HIV Surveillance Procedure Manual. iii. Xxxxxx completed case report forms to Central Office Consultants weekly upon completion of data entry into the current HIV Surveillance reporting database. iv. Collect reports of HIV and AIDS cases diagnosed and/or treated, treated which health care providers (e.g., physicians, HIV service providers, etc.) are required to complete make under TAC Title 25, Part 1, Chapter 97, Subchapter F, Rule §97.132. iv. v. Collect reports of pediatric HIV and AIDS cases diagnosed and/or treated, infants born exposed to HIV, and HIV-positive pregnant women living with HIV diagnosed and/or treated, treated which health care providers (e.g., physicians, HIV service providers, etc.) and laboratories are required to complete make under TAC Title 25, Part 1, Chapter 97, Subchapter F, Rule §97.132. Grantee is responsible for collecting the reports within Grantee’s designated Service Area. For each perinatal exposure investigated, Grantee will complete shall ensure that a pediatric case report form (PCRF), is completed along with an updated adult case report form for infant’s mother. v. vi. Collect all required data elements to conduct Perinatal HIV surveillance activities, including reviewing and conducting medical record abstractions of the mother’s and child’s medical records in Xxxxxxx’s designated Service Area to properly report all perinatally exposed cases diagnosed and/or treated within Grantee’s designated Service Area. vii. Collect all required data elements to conduct HIV surveillance follow-up activities, including reviewing and conducting medical record abstractions within three months of diagnosis for all patients seen in Grantee’s designated Service Area to properly report all HIV and AIDS cases diagnosed and/or treated within Grantee’s designated Service Area. viviii. Abstract medical records requested by another jurisdiction in Texas within the timeframes time frames outlined in the HIV Surveillance Manual. viiix. Conduct an investigation to verify any reported adult and/or pediatric infant HIV or AIDS deaths and abstract medical chart when appropriate within Grantee’s designated Service Area. viii. x. Follow procedures as outlined in Texas HIV Surveillance Procedure Manual to conduct out-of-out of state record searches. ixxi. Maintain an efficient tracking mechanism, either by paper or electronic file, to record outcomes for all laboratory reports received by local site (including all laboratory reports received through Electronic Laboratory Report and all paper laboratory reports received directly from providers or labs). With an efficient tracking mechanism in place, Grantee should be able to readily produce surveillance site standings at any given time (i.e., number of cases completed for the month, type of cases completed- New, Update to AIDS, perinatal exposure, pregnancy update and number of cases pending along with estimated dates of completion). Manage all laboratory reports in TB/System Agency Lab Management System, upon implementation xii. For each adult case of HIV newly entered into the current HIV Surveillance reporting database, Grantee will complete or obtain HIV Testing and Treatment History information from the reporting provider to complete the testing and treatment history data elements on the Adult Case Report Form (ACRF), an HIV/STD Integrated AIDS Case Report Addendum or other form specified by System (THISIS) Agency Program, to collect HIV Incidence Surveillance data elements as referenced in accordance with the Texas CDC Guidelines for HIV Incidence Surveillance Procedure Manualand any future revisions.

Completeness. i. Ensure completeness of case reporting provided to System Agency by conducting the following activities at least monthly: fully reviewing monthly data quality reports and regularly reviewing surveillance systems to identify any inconsistencies or gaps in laboratory reporting. Grantee is encouraged to implement additional methods of evaluating completeness of key source reporting, after first receiving System Agency written approval. ii. Ensure HIV/AIDS case report forms are accurate and complete in accordance with guidance provided in the Texas HIV Surveillance Procedure Manual. iii. Collect reports of HIV and AIDS cases diagnosed and/or treated, which health care providers (e.g., physicians, HIV service providers, etc.) are required to complete under TAC Title 25, Part 1, Chapter 97, Subchapter F, Rule §97.132. iv. Collect reports of pediatric HIV and AIDS cases diagnosed and/or treated, infants born exposed to HIV, and pregnant women living with HIV diagnosed and/or treated, which health care providers (e.g., physicians, HIV service providers, etc.) and laboratories are required to complete under TAC Title 25, Part 1, Chapter 97, Subchapter F, Rule §97.132. Grantee is responsible for collecting the reports within Grantee’s designated Service Area. For each perinatal exposure investigated, Grantee will complete a pediatric case report form (PCRF), along with an updated adult case report form (ACRF) for infant’s mother. v. Collect all required data elements to conduct HIV surveillance follow-up activities, including conducting medical record abstractions within three months of diagnosis for all patients seen in Grantee’s designated Service Area to properly report all HIV and AIDS cases diagnosed and/or treated within Grantee’s designated Service Area. vi. Abstract medical records requested by another jurisdiction in Texas within the timeframes outlined in the HIV Surveillance Manual. vii. Conduct an investigation to verify any reported adult and/or pediatric HIV or AIDS deaths and abstract medical chart when appropriate within Grantee’s designated Service Area. viii. Follow procedures as outlined in Texas HIV Surveillance Procedure Manual to conduct out-of-state record searches. ix. Manage all laboratory reports in TB/HIV/STD Integrated System (THISIS) in accordance with the Texas HIV Surveillance Procedure Manual. As needed, maintain an efficient tracking mechanism, either by paper or electronic file, to record outcomes for all laboratory reports received by local site (including all laboratory reports received through Electronic Laboratory Report and all paper laboratory reports received directly from providers or labs). With the use of THISIS and if needed, the use of an efficient tracking mechanism, Grantee should be able to readily produce surveillance site standings at any given time (i.e., number of cases reported for the month, number of medical record abstractions completed, cases with incomplete algorithms, type of cases completed (new), update to AIDS, perinatal exposure, pregnancy update and number of cases pending along with estimated dates of completion). x. In support of molecular HIV surveillance (MHS), Grantee will complete or obtain HIV Testing and Treatment History information from the reporting provider to complete the testing and treatment history data elements on the(ACRF. xi.

Completeness. i. Ensure completeness of case reporting provided to System Agency DSHS by conducting the following activities at least monthly: fully reviewing monthly data quality reports and regularly reviewing surveillance systems to identify any inconsistencies or gaps in laboratory reporting. Grantee is encouraged to implement additional methods of evaluating completeness of key source reporting, after first receiving System Agency DSHS’s written approval. ii. Ensure HIV/AIDS case report forms are accurate and complete in accordance with guidance provided in the Texas HIV Surveillance Procedure Manual. iii. Collect reports of HIV and AIDS cases diagnosed and/or treated, which health care providers (e.g., physicians, HIV service providers, etc.) are required to complete under TAC Title 25, Part 1, Chapter 97, Subchapter F, Rule §97.132. iv. Collect reports of pediatric HIV and AIDS cases diagnosed and/or treated, infants born exposed to HIV, and pregnant women living with HIV diagnosed and/or treated, which health care providers (e.g., physicians, HIV service providers, etc.) and laboratories are required to complete under TAC Title 25, Part 1, Chapter 97, Subchapter F, Rule §97.132. Grantee is responsible for collecting the reports within Grantee’s designated Service Area. For each perinatal exposure investigated, Grantee will shall complete a pediatric case report form Pediatric Case Report Form (PCRF), ) along with an updated adult case report form Adult Case Report Form (ACRF) for infant’s mother. v. Collect all required data elements to conduct HIV surveillance follow-up activities, including conducting medical record abstractions within three months of diagnosis for all patients seen in Grantee’s designated Service Area Area, to properly report all HIV and AIDS cases diagnosed and/or treated within Grantee’s designated Service Area. vi. Abstract medical records requested by another jurisdiction in Texas within the timeframes outlined in the Texas HIV Surveillance Procedure Manual. vii. Conduct an investigation to verify any reported adult and/or pediatric HIV or AIDS deaths and abstract medical chart when appropriate within Grantee’s designated Service Area. viii. Follow procedures as outlined in Texas HIV Surveillance Procedure Manual to conduct out-of-state record searches. ix. Manage all laboratory reports in TB/HIV/STD Integrated System THISIS. As needed, maintain an efficient tracking mechanism, either by paper or electronic file, to record outcomes for all laboratory reports received by local site (THISIS) in accordance including all laboratory reports received through ELR and all paper laboratory reports received directly from providers or labs). With the use of THISIS and, if needed, the use of an efficient tracking mechanism, Grantee must be able to readily produce surveillance site standings at any given time (i.e., number of cases reported for the month, number of medical record abstractions completed, cases with incomplete algorithms, type of cases completed (new), update to AIDS, perinatal exposure, pregnancy update and number of cases pending along with estimated dates of completion). x. In support of molecular HIV surveillance (MHS), complete or obtain HIV Testing and Treatment History information from the Texas HIV Surveillance Procedure Manualreporting provider to complete the testing and treatment history data elements on the Adult Case Report Form.

Completeness. i. Ensure completeness of case reporting provided to System Agency by conducting the following activities at least monthly: fully reviewing monthly data quality reports and regularly reviewing surveillance systems to identify any inconsistencies or gaps in laboratory reporting. Grantee is encouraged to implement additional methods of evaluating completeness of key reporting source reporting, after first receiving System Agency written approval. ii. Ensure HIV/AIDS case report forms are accurate and complete in accordance with guidance provided in the Texas HIV Surveillance Procedure Manual. iii. Collect reports of HIV and AIDS cases diagnosed and/or treated, treated which health care providers (e.g., physicians, HIV service providers, etc.) are required to complete make under TAC Title 25, Part 1, Chapter 97, Subchapter F, Rule §97.132. iv. Collect reports of pediatric HIV and AIDS cases diagnosed and/or treated, infants born exposed to HIV, and HIV-positive pregnant women living with HIV diagnosed and/or treated, treated which health care providers (e.g., physicians, HIV service providers, etc.) and laboratories are required to complete make under TAC Title 25, Part 1, Chapter 97, Subchapter subchapter F, Rule §97.132. Grantee is responsible for collecting the reports within Grantee’s designated Service Area. For each perinatal exposure investigated, Grantee will complete shall ensure that a pediatric case report form (PCRF), ) is completed along with an updated adult case report form for infant’s mother. v. Collect all required data elements to conduct HIV surveillance follow-up activities, including reviewing and conducting medical record abstractions within three months of diagnosis for all patients seen in Grantee’s designated Service Area to properly report all HIV and AIDS cases diagnosed and/or treated within Grantee’s designated Service Area. vi. Abstract medical records requested by another jurisdiction in Texas within the timeframes time frames outlined in the HIV Surveillance Manual. vii. Conduct an investigation to verify any reported adult and/or pediatric infant HIV or AIDS deaths and abstract medical chart when appropriate within Grantee’s designated Service Area. viii. Follow procedures as outlined in Texas HIV Surveillance Procedure Manual to conduct out-of-out of state record searches. ix. Maintain an efficient tracking mechanism, either by paper or electronic file, to record outcomes for all laboratory reports received by local site (including all laboratory reports received through Electronic Laboratory Report and all paper laboratory reports received directly from providers or labs). With an efficient tracking mechanism in place, Grantee should be able to readily produce surveillance site standings at any given time (i.e., number of cases reported for the month, number of medical record abstractions completed, cases with incomplete algorithms, type of cases completed- new, update to AIDS, perinatal exposure, pregnancy update and number of cases pending along with estimated dates of completion). Manage all laboratory reports in TB/HIV/STD Integrated System (THISIS) in accordance with Agency Lab Management System, upon implementation. x. For each adult case of HIV newly entered into the Texas current HIV Surveillance Procedure Manualreporting database, Grantee will complete or obtain HIV Testing and Treatment History information from the reporting provider to complete the testing and treatment history data elements on the Adult Case Report Form (ACRF).

Completeness. i. Ensure Grantee shall ensure completeness of case reporting provided to System Agency by conducting the following activities at least monthly: fully reviewing monthly data quality reports and regularly reviewing surveillance systems to identify any inconsistencies or gaps in laboratory reporting. Grantee is encouraged to implement additional methods of evaluating completeness of key source reporting, after first receiving System Agency written approval. ii. Ensure Grantee shall ensure HIV/AIDS case report forms are accurate and complete in accordance with guidance provided in the Texas HIV Surveillance Procedure Manual. iii. Collect Grantee shall collect reports of HIV and AIDS cases diagnosed and/or or treated, which health care providers (e.g., physicians, HIV service providers, etc.) are required to complete under TAC Title 25, Part 1, Chapter 97, Subchapter F, Rule §97.132. iv. Collect Grantee shall collect reports of pediatric HIV and AIDS cases diagnosed and/or or treated, infants born exposed to HIV, and pregnant women living with HIV diagnosed and/or or treated, which health care providers (e.g., physicians, HIV service providers, etc.) and laboratories are required to complete under TAC Title 25, Part 1, Chapter 97, Subchapter F, Rule §97.132. Grantee is responsible for collecting the reports within Grantee’s designated Service Area. For each perinatal exposure investigated, Grantee will shall complete a pediatric case report form Pediatric Case Report Form (PCRF), ) along with an updated adult case report form Adult Case Report Form (ACRF) for infant’s mother. v. Collect . Grantee shall collect all required data elements to conduct HIV surveillance follow-up activities, including conducting medical record abstractions within three months of diagnosis for all patients seen in Grantee’s designated Service Area Area, to properly report all HIV and AIDS cases diagnosed and/or or treated within Grantee’s designated Service Area. vi. Abstract Grantee shall abstract medical records requested by another jurisdiction in Texas within the timeframes outlined in the HIV Surveillance Manual. vii. Conduct Grantee shall conduct an investigation to verify any reported adult and/or or pediatric HIV or AIDS deaths and abstract medical chart chart, when appropriate appropriate, within Grantee’s designated Service Area. viii. Follow Grantee shall follow procedures as outlined in Texas HIV Surveillance Procedure Manual to conduct out-of-state record searches. ix. Manage Grantee shall manage all laboratory reports in TB/HIV/STD Integrated System (THISIS) ). As needed, maintain an efficient tracking mechanism, either by paper or electronic file, to record outcomes for all laboratory reports received by local site (including all laboratory reports received through ELR and all paper laboratory reports received directly from providers or labs). With the use of THISIS and, if needed, the use of an efficient tracking mechanism, Grantee must be able to readily produce surveillance site standings at any given time (i.e., number of cases reported for the month, number of medical record abstractions completed, cases with incomplete algorithms, type of cases completed (new), update to AIDS, perinatal exposure, pregnancy update and number of cases pending along with estimated dates of completion). Grantee shall complete or obtain HIV Testing and Treatment History information from the reporting provider, in accordance with support of molecular HIV surveillance (MHS), to complete the Texas HIV Surveillance Procedure Manualtesting and treatment history data elements on the Adult Case Report Form (ACRF).

Completeness. i. Ensure a. Grantee shall ensure completeness of case reporting provided to System Agency by conducting the following activities at least monthly: fully reviewing monthly data quality reports and regularly reviewing surveillance systems to identify any inconsistencies or gaps in laboratory reporting. Grantee is encouraged to implement additional methods of evaluating completeness of key source reporting, after first receiving System Agency written approval. ii. Ensure b. Grantee shall ensure HIV/AIDS case report forms are accurate and complete in accordance with guidance provided in the Texas HIV Surveillance Procedure Manual. iii. Collect c. Grantee shall collect reports of HIV and AIDS cases diagnosed and/or or treated, which health care providers (e.g., physicians, HIV service providers, etc.) are required to complete under TAC Title 25, Part 1, Chapter 97, Subchapter F, Rule §97.132. iv. Collect d. Grantee shall collect reports of pediatric HIV and AIDS cases diagnosed and/or or treated, infants born exposed to HIV, and pregnant women living with HIV diagnosed and/or or treated, which health care providers (e.g., physicians, HIV service providers, etc.) and laboratories are required to complete under TAC Title 25, Part 1, Chapter 97, Subchapter F, Rule §97.132. Grantee is responsible for collecting the reports within Grantee’s designated Service Area. For each perinatal exposure investigated, for e. Grantee will complete a pediatric case report form (PCRF), along with an updated adult case report form for infant’s mother. v. Collect shall collect all required data elements to conduct HIV surveillance follow-up activities, including conducting medical record abstractions within three months of diagnosis for all patients seen in Grantee’s designated Service Area Area, to properly report all HIV and AIDS cases diagnosed and/or or treated within Grantee’s designated Service Area. vi. Abstract f. Grantee shall abstract medical records requested by another jurisdiction in Texas within the timeframes outlined in the HIV Surveillance Manual. vii. Conduct g. Grantee shall conduct an investigation to verify any reported adult and/or or pediatric HIV or AIDS deaths and abstract medical chart chart, when appropriate appropriate, within Grantee’s designated Service Area. viii. Follow h. Grantee shall follow procedures as outlined in Texas HIV Surveillance Procedure Manual to conduct out-of-state record searches. ix. Manage i. Grantee shall manage all laboratory reports in TB/HIV/STD Integrated System (THISIS) ). As needed, maintain an efficient tracking mechanism, either by paper or electronic file, to record outcomes for all laboratory reports received by local site (including all laboratory reports received through ELR and all paper laboratory reports received directly from providers or labs). With the use of THISIS and, if needed, the use of an efficient tracking mechanism, Grantee must be able to readily produce surveillance site standings at any given time (i.e., number of cases reported for the month, number of medical record abstractions completed, cases with incomplete algorithms, type of cases completed (new), update to AIDS, perinatal exposure, pregnancy update and number of cases pending along with estimated dates of completion). j. Grantee shall complete or obtain HIV Testing and Treatment History information from the reporting provider, in accordance with support of molecular HIV surveillance (MHS), to complete the Texas HIV Surveillance Procedure Manualtesting and treatment history data elements on the Adult Case Report Form (ACRF).