**APPENDIX B**

# INVESTIGATOR'S STUDY FILE CHECKLIST

Final signed protocol.

Final signed amendments, if applicable.

Final signed FDA 1572, if applicable.

All amended FDA 1572, if applicable.

CVs of PI with state license information.

CVs of clinical research staff (study coordinators, etc., optional).

Clinic staff -- roles and responsibilities/signatures.

Copy of approved ICD.

Copy of IRB and R&D Committee approval for original protocol,
advertisements, and ICD.

Copy of approved advertisements.

Copies of IRB approvals for all amendments.

Copies of IRB correspondence, progress reports, and closeout letter.

All internal and external communications relating to the study, such as
letters, memos, and phone contacts (telephone/communications log)
including site-sponsor correspondence.

Other correspondence/notes-to-file.

Log of monitoring visits and any reports.

Log of study related training.

Subject log.

Individual patient records and source documents.

Lab certification and lab normal values each lab uses, if applicable.
Copies of lab shipment documentation, if applicable.

Original or copy of drug/device log for investigational drug/device,
concomitant medications, and equipment, if applicable. Copies of
drug/device shipment and retrieval documents, if applicable.

Copies of any information relating to the drug/devices used in this
study, if applicable.

At the end of the study, a copy of the drug/device randomization codes,
if applicable.

Information of any serious or adverse events at this site including any
IRB submission information, if applicable.

After completion of study, original of all CRFs and any other data forms
including lab test data for this study, if applicable.

Investigator\'s Brochure, if applicable.

Final study summary report to the IRB (including protocol termination
report form).

Any other pertinent study information.

**NOTE: This binder is to serve as a repository and directory for all
study documents at the Investigator's site. This binder will contain
either the documents or a listing of alternate storage locations.**

**PROTOCOL**

-   Initial approved protocol and all revisions.

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-   Addenda, appendices, amendments.

List protocol versions filed: (Identify by date)

Alternate locations(s) if not filed in this binder

Item Location

**SUPPLEMENTAL PROTOCOL INSTRUCTIONS**

-   Operations manual.

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-   Other supplemental information provided by Sponsor.

List information filed: (Identify by date)

Alternate locations(s) if not filed in this binder

Item Location

**CASE REPORT FORMS**

-   Blank master case report forms.

List case report forms versions filed: (Identify by date)

Alternate locations(s) if not filed in this binder

Item Location

**INVESTIGATOR BROCHURE**

-   Current version and all revisions.

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-   Supplemental information provided by Sponsor.

List versions and supplemental information filed: (Identify by date)

Alternate locations(s) if not filed in this binder

Item Location

**CONSENT DOCUMENTS/ INFORMATION FOR PATIENTS**

-   Unsigned copies of all IRB approved consent document versions.

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-   Other IRB approved information and instructions for patients.

-   All approved advertising.

***NOTE:** File correspondence concerning submission and approval of
these documents in the IRB Correspondence Section.*

List versions and other information filed: (Identify by date)

**SUBJECT LOG**

-   List of all patients screened (consented), enrolled, terminated.

Alternate locations(s) if not filed in this binder

Item Location

SUBJECT LOG

(A record of all subjects signing consent)

Page of

Investigator: Project:

Study Site: Sponsor:

+-------+-------+-----------------------------+-------+-------+-------+
| *     | **CO  | **RANDOMIZATION DATE AND    | **D   | **REA | **VA  |
| *SCRE | NSENT | NUMBER**                    | ATE** | SON** | OR**  |
| ENING | D     |                             |       |       |       |
| D     | ATE** | **(OR REASON NOT            | **TE  | **TE  | **NON |
| ATE** |       | RANDOMIZED)**               | RMINA | RMINA | -VA** |
|       |       |                             | TED** | TED** |       |
+-------+-------+-----------------------------+-------+-------+-------+
|       |       |                             |       |       |       |
+-------+-------+-----------------------------+-------+-------+-------+
|       |       |                             |       |       |       |
+-------+-------+-----------------------------+-------+-------+-------+
|       |       |                             |       |       |       |
+-------+-------+-----------------------------+-------+-------+-------+
|       |       |                             |       |       |       |
+-------+-------+-----------------------------+-------+-------+-------+
|       |       |                             |       |       |       |
+-------+-------+-----------------------------+-------+-------+-------+
|       |       |                             |       |       |       |
+-------+-------+-----------------------------+-------+-------+-------+
|       |       |                             |       |       |       |
+-------+-------+-----------------------------+-------+-------+-------+
|       |       |                             |       |       |       |
+-------+-------+-----------------------------+-------+-------+-------+
|       |       |                             |       |       |       |
+-------+-------+-----------------------------+-------+-------+-------+
|       |       |                             |       |       |       |
+-------+-------+-----------------------------+-------+-------+-------+

**SERIOUS ADVERSE EVENTS/SAFETY REPORTS**

-   Serious adverse events log.

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-   Investigator safety reports to Sponsor (per protocol instructions,
    report to IRB if required).

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-   IND safety reports received from Sponsor (report to IRB).

Alternate locations(s) if not filed in this binder

Item Location

SERIOUS ADVERSE EVENTS LOG

Investigator: Project:

Study Site: Sponsor:

+-------+-------+-----+----------------+------+-------+-----+------+
| *     | *     | **  | **EVENT**      | *    | **D   | **  | **I  |
| *DATE | *DATE | PAT |                | *SAE | ATE** | DAT | RB** |
| SAE** | LEAR  | IEN |                | FO   |       | E** |      |
|       | NED** | T** |                | RM** | **    |     | **   |
| **    |       |     |                |      | REPOR | **R | RESP |
| OCCUR | **OF  | *   |                | *    | TED** | EPO | ONSE |
| RED** | EV    | *NU |                | *COM |       | RTE | \*** |
|       | ENT** | MBE |                | PLET | **TO  | D** |      |
|       |       | R** |                | ED** | SPON  |     |      |
|       |       |     |                |      | SOR** | *   |      |
|       |       |     |                | *    |       | *TO |      |
|       |       |     |                | *(Y/ |       | I   |      |
|       |       |     |                | N)** |       | RB\ |      |
|       |       |     |                |      |       | *** |      |
+-------+-------+-----+----------------+------+-------+-----+------+
|       |       |     |                |      |       |     |      |
+-------+-------+-----+----------------+------+-------+-----+------+
|       |       |     |                |      |       |     |      |
+-------+-------+-----+----------------+------+-------+-----+------+
|       |       |     |                |      |       |     |      |
+-------+-------+-----+----------------+------+-------+-----+------+
|       |       |     |                |      |       |     |      |
+-------+-------+-----+----------------+------+-------+-----+------+
|       |       |     |                |      |       |     |      |
+-------+-------+-----+----------------+------+-------+-----+------+
|       |       |     |                |      |       |     |      |
+-------+-------+-----+----------------+------+-------+-----+------+
|       |       |     |                |      |       |     |      |
+-------+-------+-----+----------------+------+-------+-----+------+
|       |       |     |                |      |       |     |      |
+-------+-------+-----+----------------+------+-------+-----+------+
|       |       |     |                |      |       |     |      |
+-------+-------+-----+----------------+------+-------+-----+------+
|       |       |     |                |      |       |     |      |
+-------+-------+-----+----------------+------+-------+-----+------+

**\***File correspondence regarding IRB reports in the IRB
Correspondence Section

**IRB CORRESPONDENCE**

-   IRB membership list and updates or other assurance of proper
    constitution.

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-   Documents indicating IRB approval of protocol, amendments, addenda,
    appendices, subject information sheets, consent form(s), recruitment
    tools.

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-   Documentation of annual approval of continuation of trial and
    related documents.

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-   Annual progress reports and other reports required by IRB.

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-   Copies of Investigator notification to IRB of IND Safety Reports
    received from the Sponsor.

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-   Copies of Investigator notification to IRB of serious adverse events
    and other unanticipated problems at the site.

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-   Copies of other Investigator-IRB correspondence.

Alternate locations(s) if not filed in this binder

Item Location

IRB CORRESONDENCE LOG

Investigator: Project:

Study Site: Sponsor:

1\. Date: / /

Reply/Action Taken:

2\. Date: / /

Reply/Action Taken:

3\. Date: / /

Reply/Action Taken:

**IRB CORRESONDENCE LOG (CONTINUED)**

\# Date: / /

Reply/Action Taken:

\# Date: / /

Reply/Action Taken:

\# Date: / /

Reply/Action Taken:

**SITE-SPONSOR CORRESPONDENCE**

-   Correspondence between Investigator and Sponsor.

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-   Correspondence between Investigator and Monitor.

-   Investigator meeting agenda and notes.

-   Study newsletter(s).

-   Clinical study results received form Sponsor.

List filed: (Identify by date)

Alternate locations(s) if not filed in this binder

Item Location

**OTHER CORRESPONDENCE/NOTES-TO-FILE**

-   Documentation of unusual events or communications (Sponsor
    authorization for protocol departure).

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-   Patient specific notes to file (original notes-to-file shall be
    filed in patient's medical record).

List filed: (Identify by date)

Alternate locations(s) if not filed in this binder

Item Location

INVESTIGATOR'S NOTES-TO-FILE

Investigator: Project:

Study Site: Sponsor:

Patient #: Date:

Check the appropriate Good Clinical Practices non-compliance or protocol
irregularity/non-compliance issue as applies:

#  ICD signed after patient started study procedures 

Safety labs not collected as specified by the protocol

Inclusion/Exclusion criteria violated

Patient in simultaneous interventional trials

Required source data documentation could not be obtained

SAE not reported appropriately to the MUSC IRB

SAE not reported appropriately to the Sponsor

Drug accountability issue

Subject took excluded medication

Subject did not return study drug

Subject did not take medication as directed

Subject received the wrong study drug

Subject was seen outside the allowed visit interval

Required study procedure not completed

Other: (Specify)

Explain the reason for the irregularity/non-compliance issue(s):

Date Sponsor notified: / /

Date IRB notified: / /

Study Coordinator: Date:

(Signature)

Investigator: Date:

(Signature)

(***NOTE:*** File a copy with subject's records if related to a specific
patient)

**TELEPHONE/COMMUNICATIONS LOG**

-   Log of telephone communications with Sponsor's representative.

Alternate locations(s) if not filed in this binder

Item Location

TELEPHONE COMMUNICATIONS LOG

Investigator: Project:

Study Site: Sponsor:

-   Record chronologically all telephone contacts with the Sponsor or
    MUSC IRB

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-   Sign and date each entry

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-   Discussion concerning a specific study subject should be noted in
    the records for that subject

  ---------- ------------- ---------------------------------- ---------------
  **DATE**   **PERSON**    **TOPIC/DISCUSSION**               **SIGNATURE**

  / /                                                         

  / /                                                         

  / /                                                         

  / /                                                         

  / /                                                         

  / /                                                         

  / /                                                         

  / /                                                         

  / /                                                         

  / /                                                         
  ---------- ------------- ---------------------------------- ---------------

**SITE STAFF -- ROLES, RESPONSIBILITIES, AND SIGNATURES**

-   Site personnel signature log.

-   Records of study personnel training including:

> 1\. Investigator meetings (agendas and/or minutes).
>
> 2\. Monitoring training of site personnel.
>
> 3\. Other staff training provided by Investigator and/or Sponsor.

Alternate locations(s) if not filed in this binder

Item Location

SITE STAFF - ROLES, RESPONSIBILITIES & SIGNATURES

Investigator: Project:

Study Site: Sponsor:

+-------------+-----------+---------------+-----------------+--------+
| **NAME**    | **P       | **RES         | **SIGNATURE**   | **PI** |
|             | OSITION** | PONSIBILITY** |                 |        |
|             |           |               |                 | **INIT |
|             |           | **CODE(S)\*** |                 | IALS** |
+-------------+-----------+---------------+-----------------+--------+
|             |           |               |                 |        |
+-------------+-----------+---------------+-----------------+--------+
|             |           |               |                 |        |
+-------------+-----------+---------------+-----------------+--------+
|             |           |               |                 |        |
+-------------+-----------+---------------+-----------------+--------+
|             |           |               |                 |        |
+-------------+-----------+---------------+-----------------+--------+
|             |           |               |                 |        |
+-------------+-----------+---------------+-----------------+--------+
|             |           |               |                 |        |
+-------------+-----------+---------------+-----------------+--------+
|             |           |               |                 |        |
+-------------+-----------+---------------+-----------------+--------+
|             |           |               |                 |        |
+-------------+-----------+---------------+-----------------+--------+
|             |           |               |                 |        |
+-------------+-----------+---------------+-----------------+--------+
|             |           |               |                 |        |
+-------------+-----------+---------------+-----------------+--------+

**\* List major tasks, e.g. administer study drug, blood draws, obtain
informed consent, physical exams, etc.**

**[RESPONSIBILITY CODES:]{.underline}**

A= Make eligibility/termination decisions E= Evaluate AE
(cause/severity)

B= Obtain informed consent F= Prescribe study drugs/devices

C= Direct medical care of subjects (treatment decisions) G= Label and
dispense study drugs

D= Make data entries and corrections on CRFs H= Maintain drug
accountability records

Others (specify):

I= K=

J= L=

**TO BE SIGNED AT SITE CLOSURE:**

I confirm that this list accurately reflects the delegation of
responsibilities during the study.

PI Signature Date:

**INVESTIGATIONAL PRODUCT ACCOUNTABILITY**

-   Copy of drug shipment invoices.

-   Copy of dispensing records (pharmacy and/or clinic).

-   Copy of drug disposition records (destruction or return to Sponsor).

-   Instructions for storing and dispensing investigational product
    (drug treatment and handling protocol).

-   Treatment decoding information for emergencies, if applicable.

Alternate locations(s) if not filed in this binder

Item Location

**REGULATORY DOCUMENTS**

-   Signed 1572

-   OPRR Project Assurance Documentation (if applicable).

-   CV(s)

-   DEA Certificate (if applicable).

-   Lab Certificate(s).

-   Lab Normals

-   Investigator Confidentiality Agreement (if applicable).

-   Investigator Conflict of Interest (if applicable).

-   Sign-in log for Sponsor representatives.

Alternate locations(s) if not filed in this binder

Item Location

**SUBJECT FILES AND SOURCE DOCUMENTS**

-   Ineligible subject(s) records. **\*\***

-   Study subject records including: **\*\***

> 1\. Signed consent form.
>
> 2\. Copies of completed CRFs.

3\. Source documents and correspondence related to specific study
subject.

4\. Copies of data edits.

**\*\* *NOTE****: Subject's files will consist of individualized CRFs
(hardcopy and/or electronic) and the medical record/chart of each
subject.*

Alternate locations(s) if not filed in this binder

Item Location

**TRAINING LOG**

-   Record chronologically all training

Alternate locations(s) if not filed in this binder

Item Location

TRAINING LOG

Investigator: Project:

Study Site: Sponsor:

-   Record chronologically all training

  -------------- ----------------- ------------------ -------------- ----------
  **NAME**       **STUDY           **TRAINING         **PROVIDER**   **DATE**
                 POSITION**        RECEIVED**                        

                                                                     / /

                                                                     / /

                                                                     / /

                                                                     / /

                                                                     / /

                                                                     / /

                                                                     / /

                                                                     / /

                                                                     / /

                                                                     / /
  -------------- ----------------- ------------------ -------------- ----------

**VISITOR LOG**

-   Record all study related visitors

Alternate locations(s) if not filed in this binder

Item Location

VISITOR LOG

Investigator: Project:

Study Site: Sponsor:

  ------------------ --------------------------- ------------------------
  **DATE OF VISIT**  **PURPOSE OF VISIT**        **VISITOR\'S NAME**

  / /                                            

  / /                                            

  / /                                            

  / /                                            

  / /                                            

  / /                                            

  / /                                            

  / /                                            

  / /                                            

  / /                                            
  ------------------ --------------------------- ------------------------