Frederic C. Bartter GCRC

Data and Safety Monitoring Plan (DSMP)

And

Assurance Document

 

Project Title:                                                                        Risk Level*:

 

IRB Protocol Number:     

 

Principal Investigator:

 

Co-Investigators:     

 

* - risk level is determined from the risk assessment form found on the GCRC website.

I.    The entity that will be responsible for monitoring the conduct of the study (initial all that apply): 

___  The PI or Study Coordinator will perform an annual safety review which will be submitted to the IRB and the GCRC.

___  An independent monitor will perform a safety review every _____ [time interval] and the P.I. will ensure that a report is sent to the IRB and GCRC.

___  The PI will supply a report from a data and safety monitoring board [DSMB]**, an independent DSMB or a data safety monitoring committee (DSC), annually regarding data and safety monitoring for this protocol. (A DSMB is required for high risk studies. See (Risk Review Form) **name(s) of DSMB members and charter submission to GCRC required:

Please note: any adverse event (AE) related to this study must be recorded and included in the PI Annual Report to GCRC office, c/o the RSA. To report a serious or unexpected adverse event (AE), complete a copy of the IRB adverse event form and send to the UTHSC IRB office. A copy needs to be sent to the GCRC RSA within 15 days from occurrence. 

II. The following elements will be monitored throughout the study research period as acknowledged by the P.I.’s initials. Any “not applicable” (N/A) must be explained in the last column.  

Monitoring elements

Reference cited
(JCAHO 2004 manual)

initials

N/A

Explanation of N/A

The quality and content of the informed consent, and the consent process will be monitored throughout the study period and changes will be communicated to the IRB and the GAC.

 

Cited in the protocol,
p. ____.

 

 

 

The accuracy of the collection and processing of laboratory specimens will be monitored throughout the study period.

JCAHO accreditation manual, pp. PC-47 to PC-50 (Standards PC 16.10, 16.20, 16.30, 16.40, 16.50, 16.60).

 

 

 

The timeliness and conformity with established clinical monitoring of the subject will be followed.

Cited in the protocol,
p. ____.

 

 

 

The forms in the subjects’ medical records will be current and maintained in a timely manner.

JCAHO accreditation manual,
pp. IM-14 to IM-18 (Standards IM 6.10, 6.20, 6.30, 6.40, 6.50).

 

 

 

The confidentiality of the subject will be maintained.

Cited in the protocol, p. ____ as referenced on IRB protocol form, Part I., #11.

 

 

 

The timeliness and accuracy of all information documented in any forms and/or records pertaining to the study will be maintained.

Cited in the protocol, p. ____; JCAHO accreditation manual, p. IM-14 (Standard IM. 6.10).

 

 

 

III. The following environmental elements will be monitored throughout the study- research period as acknowledged by the P.I.’s initials. Any “not applicable” (N/A) must be explained in the last column.

Monitoring elements

Reference Cited

initials

N/A

Explanation of N/A

The safe handling of drugs, which includes the use of protective equipment and disposal of waste will be maintained prior to the start of the study and throughout the study period.

Cited in the protocol, p. ____

VA policies: 001-02-16;
001-02-19; 119-99-05.

JCAHO accreditation manual, p. MM-15, EC-11 (Standard MM 4.40, EC 3.10).

 

 

 

The condition of the physical space used by the investigator and subject for study purposes will be monitored prior to the start of the study and throughout the study period.

VA policy: 001-02-34

JCAHO accreditation manual, p. EC-10, EC-24 (Standard EC 2.10, 8.10).

 

 

 

The safety assurance and condition of any electrical, radiological, magnetic, gaseous, and hazardous equipment, tools, or apparatus that will be used by the investigators and subjects will be monitored prior to the start of the study and throughout the study period.

 

VA policies: 138-02-19;
001-02-16; 001-02-41;
11R-02-02; 002-01-08;
001-02-24.

JCAHO accreditation manual, pp. EC-18 to EC-20 (Standards EC 6.10).

 

 

 

 

The physical safety and security of the staff prior to the start of the study and throughout the study period will be maintained.

 

VA policies: 138-01-06;
001-02-21; 151-02-04.
JCAHO accreditation manual, p. APR-9 (Standard APR-22).

 

 

 

The physical and mental condition of the subject, particularly related to toxicity, concurrent medication use, or any type of adverse event will be assessed and monitored prior to beginning the study, throughout the study period, and up to thirty days after the last dose of an investigational drug.

Cited in the protocol, p. ____; as referenced on IRB protocol form, Part I., #9.

VA policy: 119-01-01.

 

 

 

IV. The following informed consent parameters (A. – H.) will be monitored throughout the study-research period as acknowledged by the P.I.’s initials in the box ¨ below.

 ¨           All of the following informed consent elements* are part of the consent form and consistent with the protocol descriptions.

A.   A statement that the study involves research, which includes an explanation of the research and the expected duration of the subject’s   participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

B.   A description of any reasonably foreseeable risks or discomforts to the subject;

C.   A description of any benefits to the subject or to others which may reasonably be expected from the research;

D.   A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

E.   A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the FDA may inspect the records;

F.   For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatment are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

G.   An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and to whom to contact in the event of a research-related injury to the subject;

H.   A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

* A, B, C, D, and H are also part of the JCAHO standards RI.2.180, p. RI-15 of the 2004 Accreditation Manual.

V. The investigator is expected to maintain a file of documents and records relating to the conduct of the study. This documentation includes, but is not limited to, the following elements. The following documentation elements (A. – D.) will be monitored throughout the study-research period as acknowledged by the P.I.’s initials in the box ¨ below.

 

 

 ¨   All of the following documentation elements are part of the record keeping process and consistent with IRB, GAC, and R&D expectations.

A.   Signed final protocol, and, approved and date protocol amendments will be maintained with copies provided to GAC.

B.   Records of receipt and disposition of all drug supplies will be maintained

C.   Advertising for subject participation will be monitored and changes submitted to the GAC. IRB approvals, correspondence, and reports will be maintained with copies provided to GAC.

D.   Source documents corresponding to data collection required by the protocol; documentation of sponsor/monitor contacts, including visit log and correspondence will be maintained.

VI. The following elements will be monitored throughout the study-research period as acknowledged by the P.I.’s initials. Any “not applicable” (N/A) must be explained in the last column.

Monitoring elements

Reference Cited

initials

N/A

Explanation of N/A

Grading and attribution scale will be maintained and kept current by the investigator.

Cited in the protocol, p. ____ and referenced on IRB form,
Part I., # 8 and # 9.

 

 

 

Plan for unanticipated AE reporting will be followed by the investigator.

Cited in the protocol, p. ____ and referenced on IRB form,
Part I., # 9; JCAHO P1.3.20

 

 

 

Plan for annual reporting of AEs will be followed by the investigator.

Cited in the protocol, p. ____ and referenced on IRB form,
Part I., #9.

 

 

 

AEs will be reported by the investigator to the IRB, sponsor, and GAC.

Cited in the protocol, p. ____ and referenced on IRB form,
Part I., #9.

 

 

 

 

With my signature, as the Principal Investigator, I am assuring that the aforementioned elements will be monitored and policies / standards adhered to. Also, I understand that any changes to the protocol and/or consent will be communicated to the IRB, with a copy of the correspondence sent to the GCRC office. Protocol / consent changes and adverse events reported to the IRB will also be communicated to the VA R&D and GCRC offices.

 

 

__________________________________________     ___________________

Principal Investigator                                                               Date Signed