+-----------------------------------+-----------------------------------+
| **DRUG (IND)**                    | **DEVICE (IDE)**                  |
+===================================+===================================+
| **21 CFR 50.3 Definitions \[same  | **21 CFR 50.3 Definitions \[same  |
| as 21 CFR 56.102(h)\]**           | as 21 CFR 56.102(h)\]**           |
|                                   |                                   |
| \(d\) *Investigator* means an     | \(d\) *Investigator* means an     |
| individual who actually conducts  | individual who actually conducts  |
| a clinical investigation, (i.e.,  | a clinical investigation, (i.e.,  |
| under whose immediate direction   | under whose immediate direction   |
| the test article is administered  | the test article is administered  |
| or dispensed to, or used          | or dispensed to, or used          |
| involving, a subject), or, in the | involving, a subject), or, in the |
| event of an investigation         | event of an investigation         |
| conducted by a team of            | conducted by a team of            |
| individuals, is the responsible   | individuals, is the responsible   |
| leader of that team.              | leader of that team.              |
+-----------------------------------+-----------------------------------+
| **21 CFR 50.20 General            | **21 CFR 50.20 General            |
| requirements for informed         | requirements for informed         |
| consent.**                        | consent.**                        |
|                                   |                                   |
| Except as provided in §§ 50.23    | Except as provided in §§ 50.23    |
| and 50.24, no investigator may    | and 50.24, no investigator may    |
| involve a human being as a        | involve a human being as a        |
| subject in research covered by    | subject in research covered by    |
| these regulations unless the      | these regulations unless the      |
| investigator has obtained the     | investigator has obtained the     |
| legally effective informed        | legally effective informed        |
| consent of the subject or the     | consent of the subject or the     |
| subject's legally authorized      | subject's legally authorized      |
| representative. An investigator   | representative. An investigator   |
| shall seek such consent only      | shall seek such consent only      |
| under circumstances that provide  | under circumstances that provide  |
| the prospective subject or the    | the prospective subject or the    |
| representative sufficient         | representative sufficient         |
| opportunity to consider whether   | opportunity to consider whether   |
| or not to participate and that    | or not to participate and that    |
| minimize the possibility of       | minimize the possibility of       |
| coercion or undue influence. The  | coercion or undue influence. The  |
| information that is given to the  | information that is given to the  |
| subject or the representative     | subject or the representative     |
| shall be in language              | shall be in language              |
| understandable to the subject or  | understandable to the subject or  |
| the representative. No informed   | the representative. No informed   |
| consent, whether oral or written, | consent, whether oral or written, |
| may include any exculpatory       | may include any exculpatory       |
| language through which the        | language through which the        |
| subject or the representative is  | subject or the representative is  |
| made to waive or appear to waive  | made to waive or appear to waive  |
| any of the subject's legal        | any of the subject's legal        |
| rights, or releases or appears to | rights, or releases or appears to |
| release the investigator, the     | release the investigator, the     |
| sponsor, the institution, or its  | sponsor, the institution, or its  |
| agents from liability for         | agents from liability for         |
| negligence.                       | negligence.                       |
+-----------------------------------+-----------------------------------+
| **21 CFR 50.23 Exception from     | **21 CFR 50.23 Exception from     |
| general requirements.**           | general requirements.**           |
|                                   |                                   |
| \(a\) The obtaining of informed   | \(a\) The obtaining of informed   |
| consent shall be deemed feasible  | consent shall be deemed feasible  |
| unless, before use of the test    | unless, before use of the test    |
| article (except as provided in    | article (except as provided in    |
| paragraph (b) of this section),   | paragraph (b) of this section),   |
| both the investigator and a       | both the investigator and a       |
| physician who is not otherwise    | physician who is not otherwise    |
| participating in the clinical     | participating in the clinical     |
| investigation certify in writing  | investigation certify in writing  |
| all of the following:             | all of the following:             |
|                                   |                                   |
| \(1\) The human subject is        | \(1\) The human subject is        |
| confronted by a life-threatening  | confronted by a life-threatening  |
| situation necessitating the use   | situation necessitating the use   |
| of the test article.              | of the test article.              |
|                                   |                                   |
| \(2\) Informed consent cannot be  | \(2\) Informed consent cannot be  |
| obtained from the subject because | obtained from the subject because |
| of an inability to communicate    | of an inability to communicate    |
| with, or obtain legally effective | with, or obtain legally effective |
| consent from, the subject.        | consent from, the subject.        |
|                                   |                                   |
| \(3\) Time is not sufficient to   | \(3\) Time is not sufficient to   |
| obtain consent from the subject's | obtain consent from the subject's |
| legal representative.             | legal representative.             |
|                                   |                                   |
| \(4\) There is available no       | \(4\) There is available no       |
| alternative method of approved or | alternative method of approved or |
| generally recognized therapy that | generally recognized therapy that |
| provides an equal or greater      | provides an equal or greater      |
| likelihood of saving the life of  | likelihood of saving the life of  |
| the subject.                      | the subject.                      |
|                                   |                                   |
| \(b\) If immediate use of the     | \(b\) If immediate use of the     |
| test article is, in the           | test article is, in the           |
| investigator's opinion, required  | investigator's opinion, required  |
| to preserve the life of the       | to preserve the life of the       |
| subject, and time is not          | subject, and time is not          |
| sufficient to obtain the          | sufficient to obtain the          |
| independent determination         | independent determination         |
| required in paragraph (a) of this | required in paragraph (a) of this |
| section in advance of using the   | section in advance of using the   |
| test article, the determinations  | test article, the determinations  |
| of the clinical investigator      | of the clinical investigator      |
| shall be made and, within 5       | shall be made and, within 5       |
| working days after the use of the | working days after the use of the |
| article, be reviewed and          | article, be reviewed and          |
| evaluated in writing by a         | evaluated in writing by a         |
| physician who is not              | physician who is not              |
| participating in the clinical     | participating in the clinical     |
| investigation.                    | investigation.                    |
|                                   |                                   |
| \(c\) The documentation required  | \(c\) The documentation required  |
| in paragraph (a) or (b) of this   | in paragraph (a) or (b) of this   |
| section shall be submitted to the | section shall be submitted to the |
| IRB within 5 working days after   | IRB within 5 working days after   |
| the use of the test article.      | the use of the test article.      |
+-----------------------------------+-----------------------------------+
| **21 CFR** **50.27 Documentation  | **21 CFR** **50.27 Documentation  |
| of informed consent.**            | of informed consent.**            |
|                                   |                                   |
| (b)(1) A written consent document | (b)(1) A written consent document |
| that ... may be read to the       | that ... may be read to the       |
| subject or the subject's legally  | subject or the subject's legally  |
| authorized representative, but,   | authorized representative, but,   |
| in any event, the investigator    | in any event, the investigator    |
| shall give either the subject or  | shall give either the subject or  |
| the representative adequate       | the representative adequate       |
| opportunity to read it before it  | opportunity to read it before it  |
| is signed.                        | is signed.                        |
+-----------------------------------+-----------------------------------+
| **21 CFR 312.60 General           | **21 CFR 812.100 General          |
| responsibilities of               | responsibilities of               |
| investigators.** An investigator  | investigators.**                  |
| is responsible for ensuring that  |                                   |
| an investigation is conducted     | An investigator is responsible    |
| according to the signed           | for ensuring that an              |
| investigator statement, the       | investigation is conducted        |
| investigational plan, and         | according to the signed           |
| applicable regulations; for       | agreement, the investigational    |
| protecting the rights, safety,    | plan and applicable FDA           |
| and welfare of subjects under the | regulations, for protecting the   |
| investigator\'s care; and for the | rights, safety, and welfare of    |
| control of drugs under            | subjects under the investigator's |
| investigation. An investigator    | care, and for the control of      |
| shall, in accordance with the     | devices under investigation. An   |
| provisions of part 50 of this     | investigator also is responsible  |
| chapter, obtain the informed      | for ensuring that informed        |
| consent of each human subject to  | consent is obtained in accordance |
| whom the drug is administered,    | with part 50 of this chapter.     |
| except as provided in Secs. 50.23 | Additional responsibilities of    |
| or 50.24 of this chapter.         | investigators are described in    |
| Additional specific               | subpart G.                        |
| responsibilities of clinical      |                                   |
| investigators are set forth in    |                                   |
| this part and in parts 50 and 56  |                                   |
| of this chapter.                  |                                   |
+-----------------------------------+-----------------------------------+
|                                   | **21 CFR 812.110 Specific         |
|                                   | responsibilities of               |
|                                   | investigators.**                  |
|                                   |                                   |
|                                   | \(a\) *Awaiting approval.* An     |
|                                   | investigator may determine        |
|                                   | whether potential subjects would  |
|                                   | be interested in participating in |
|                                   | an investigation, but shall not   |
|                                   | request the written informed      |
|                                   | consent of any subject to         |
|                                   | participate, and shall not allow  |
|                                   | any subject to participate before |
|                                   | obtaining IRB and FDA approval.   |
+-----------------------------------+-----------------------------------+
| **21CFR 312.53 Selecting          | 21 CFR 812.43 Selecting           |
| investigators and monitors.**     | investigators and monitors.       |
|                                   |                                   |
| \(c\) Obtaining information from  | \(c\) *Obtaining agreements.* A   |
| the investigator. Before          | sponsor shall obtain from each    |
| permitting an investigator to     | participating investigator a      |
| begin participation in an         | signed agreement that includes:   |
| investigation, the sponsor shall  |                                   |
| obtain the following:             | \(4\) A statement of the          |
|                                   | investigator's commitment to:     |
| \(1\) A signed investigator       |                                   |
| statement (Form FDA-1572)         | \(i\) Conduct the investigation   |
| containing:                       | in accordance with the agreement, |
|                                   | the investigational plan, this    |
| \(vi\) A commitment by the        | part and other applicable FDA     |
| investigator that he or she:      | regulations, and conditions of    |
|                                   | approval imposed by the reviewing |
| \(a\) Will conduct the study(ies) | IRB or FDA;                       |
| in accordance with the relevant,  |                                   |
| current protocol(s) and will only | 21 CFR 812.110 Specific           |
| make changes in a protocol after  | responsibilities of               |
| notifying the sponsor, except     | investigators.                    |
| when necessary to protect the     |                                   |
| safety, the rights, or welfare of | \(b\) *Compliance.* An            |
| subjects;                         | investigator shall conduct an     |
|                                   | investigation in accordance with  |
| \(b\) Will comply with all        | the signed agreement with the     |
| requirements regarding the        | sponsor, the investigational      |
| obligations of clinical           | plan, this part and other         |
| investigators and all other       | applicable FDA regulations, and   |
| pertinent requirements in this    | any conditions of approval        |
| part;                             | imposed by an IRB or FDA.         |
|                                   |                                   |
| \(c\) Will personally conduct or  | \(ii\) Supervise all testing of   |
| supervise the described           | the device involving human        |
| investigation(s);                 | subjects; and                     |
|                                   |                                   |
| \(d\) Will inform any potential   | \(iii\) Ensure that the           |
| subjects that the drugs are being | requirements for obtaining        |
| used for investigational purposes | informed consent are met.         |
| and will ensure that the          |                                   |
| requirements relating to          |                                   |
| obtaining informed consent (21    |                                   |
| CFR part 50) and institutional    |                                   |
| review board review and approval  |                                   |
| (21 CFR part 56) are met;         |                                   |
|                                   |                                   |
| \(e\) Will report to the sponsor  |                                   |
| adverse experiences that occur in |                                   |
| the course of the                 |                                   |
| investigation(s) in accordance    |                                   |
| with Sec. 312.64;                 |                                   |
|                                   |                                   |
| \(f\) Has read and understands    |                                   |
| the information in the            |                                   |
| investigator\'s brochure,         |                                   |
| including the potential risks and |                                   |
| side effects of the drug; and     |                                   |
|                                   |                                   |
| \(g\) Will ensure that all        |                                   |
| associates, colleagues, and       |                                   |
| employees assisting in the        |                                   |
| conduct of the study(ies) are     |                                   |
| informed about their obligations  |                                   |
| in meeting the above commitments. |                                   |
|                                   |                                   |
| \(vii\) A commitment by the       |                                   |
| investigator that, for an         |                                   |
| investigation subject to an       |                                   |
| institutional review requirement  |                                   |
| under part 56, an IRB that        |                                   |
| complies with the requirements of |                                   |
| that part will be responsible for |                                   |
| the initial and continuing review |                                   |
| and approval of the clinical      |                                   |
| investigation and that the        |                                   |
| investigator will promptly report |                                   |
| to the IRB all changes in the     |                                   |
| research activity and all         |                                   |
| unanticipated problems involving  |                                   |
| risks to human subjects or        |                                   |
| others, and will not make any     |                                   |
| changes in the research without   |                                   |
| IRB approval, except where        |                                   |
| necessary to eliminate apparent   |                                   |
| immediate hazards to the human    |                                   |
| subjects.                         |                                   |
+-----------------------------------+-----------------------------------+
| **21 CFR 312.61 Control of the    | **21 CFR 812.110 Specific         |
| investigational drug.**           | responsibilities of               |
|                                   | investigators.**                  |
| An investigator shall administer  |                                   |
| the drug only to subjects under   | \(c\) *Supervising device use.*   |
| the investigator\'s personal      | An investigator shall permit an   |
| supervision or under the          | investigational device to be used |
| supervision of a subinvestigator  | only with subjects under the      |
| responsible to the investigator.  | investigator's supervision. An    |
| The investigator shall not supply | investigator shall not supply an  |
| the investigational drug to any   | investigational device to any     |
| person not authorized under this  | person not authorized under this  |
| part to receive it.               | part to receive it.               |
+-----------------------------------+-----------------------------------+
| 21 CFR 312.62 Investigator        | **21 CFR 812.140 Records.**       |
| recordkeeping and record          |                                   |
| retention.                        | \(a\) *Investigator records.* A   |
|                                   | participating investigator shall  |
| \(a\) *Disposition of drug.* An   | maintain the following accurate,  |
| investigator is required to       | complete, and current records     |
| maintain adequate records of the  | relating to the investigator's    |
| disposition of the drug,          | participation in an               |
| including dates, quantity, and    | investigation:                    |
| use by subjects. If the           |                                   |
| investigation is terminated,      | \(2\) Records of receipt, use or  |
| suspended, discontinued, or       | disposition of a device that      |
| completed, the investigator shall | relate to:                        |
| return the unused supplies of the |                                   |
| drug to the sponsor, or otherwise | \(i\) The type and quantity of    |
| provide for disposition of the    | the device, the dates of its      |
| unused supplies of the drug under | receipt, and the batch number or  |
| § 312.59.                         | code mark.                        |
|                                   |                                   |
| \(b\) *Case histories*. An        | \(ii\) The names of all persons   |
| investigator is required to       | who received, used, or disposed   |
| prepare and maintain adequate and | of each device.                   |
| accurate case histories that      |                                   |
| record all observations and other | \(iii\) Why and how many units of |
| data pertinent to the             | the device have been returned to  |
| investigation on each individual  | the sponsor, repaired, or         |
| administered the investigational  | otherwise disposed of.            |
| drug or employed as a control in  |                                   |
| the investigation. Case histories | 21 CFR 812.110 Specific           |
| include the case report forms and | responsibilities of               |
| supporting data including, for    | investigators.                    |
| example, signed and dated consent |                                   |
| forms and medical records         | \(e\) *Disposing of device.* Upon |
| including, for example, progress  | completion or termination of a    |
| notes of the physician, the       | clinical investigation or the     |
| individual's hospital chart(s),   | investigator's part of an         |
| and the nurses' notes. The case   | investigation, or at the          |
| history for each individual shall | sponsor's request, an             |
| document that informed consent    | investigator shall return to the  |
| was obtained prior to             | sponsor any remaining supply of   |
| participation in the study.       | the device or otherwise dispose   |
|                                   | of the device as the sponsor      |
| \(c\) *Record retention.* An      | directs.                          |
| investigator shall retain records |                                   |
| required to be maintained under   | **21 CFR 812.140 Records**        |
| this part for a period of 2 years |                                   |
| following the date a marketing    | \(a\) *Investigator records.*     |
| application is approved for the   | Continued ...                     |
| drug for the indication for which |                                   |
| it is being investigated; or, if  | \(1\) All correspondence with     |
| no application is to be filed or  | another investigator, an IRB, the |
| if the application is not         | sponsor, a monitor, or FDA,       |
| approved for such indication,     | including required reports.       |
| until 2years after the            |                                   |
| investigation is discontinued and | \(3\) Records of each subject's   |
| FDA is notified.                  | case history and exposure to the  |
|                                   | device. Case histories include    |
|                                   | the case report forms and         |
|                                   | supporting data including, for    |
|                                   | example, signed and dated consent |
|                                   | forms and medical records         |
|                                   | including, for example, progress  |
|                                   | notes of the physician, the       |
|                                   | individual's hospital chart(s),   |
|                                   | and the nurses' notes. Such       |
|                                   | records shall include:            |
|                                   |                                   |
|                                   | \(i\) Documents evidencing        |
|                                   | informed                          |
|                                   |                                   |
|                                   | consent and, for any use of a     |
|                                   | device by the investigator        |
|                                   | without informed consent, any     |
|                                   | written concurrence of a licensed |
|                                   | physician and a brief description |
|                                   | of the circumstances justifying   |
|                                   | the failure to obtain informed    |
|                                   | consent. The case history for     |
|                                   | each individual shall document    |
|                                   | that informed consent was         |
|                                   | obtained prior to participation   |
|                                   | in the study.                     |
|                                   |                                   |
|                                   | \(ii\) All relevant observations, |
|                                   | including records concerning      |
|                                   | adverse device effects (whether   |
|                                   | anticipated or unanticipated),    |
|                                   | information and data on the       |
|                                   | condition of each subject upon    |
|                                   | entering, and during the course   |
|                                   | of, the investigation, including  |
|                                   | information                       |
|                                   |                                   |
|                                   | about relevant previous medical   |
|                                   | history and the results of all    |
|                                   | diagnostic tests.                 |
|                                   |                                   |
|                                   | \(iii\) A record of the exposure  |
|                                   | of each subject to the            |
|                                   | investigational device, including |
|                                   | the date and time of each use,    |
|                                   | and any other therapy.            |
|                                   |                                   |
|                                   | \(4\) The protocol, with          |
|                                   | documents showing the dates of    |
|                                   | and reasons for each deviation    |
|                                   | from the protocol.                |
|                                   |                                   |
|                                   | \(5\) Any other records that FDA  |
|                                   | requires to be maintained by      |
|                                   | regulation or by specific         |
|                                   | requirement for a category of     |
|                                   | investigations or a particular    |
|                                   | investigation.                    |
|                                   |                                   |
|                                   | \(d\) *Retention period.* An      |
|                                   | investigator or sponsor shall     |
|                                   | maintain the records required by  |
|                                   | this subpart during the           |
|                                   | investigation and for a period of |
|                                   | 2 years after the latter of the   |
|                                   | following two dates: The date on  |
|                                   | which the investigation is        |
|                                   | terminated or completed, or the   |
|                                   | date that the records are no      |
|                                   | longer required for purposes of   |
|                                   | supporting a premarket approval   |
|                                   | application or a notice of        |
|                                   | completion of a product           |
|                                   | development protocol.             |
|                                   |                                   |
|                                   | \(e\) *Records custody.* An       |
|                                   | investigator or sponsor may       |
|                                   | withdraw from the responsibility  |
|                                   | to maintain records for the       |
|                                   | period required in paragraph (d)  |
|                                   | of this section and transfer      |
|                                   | custody of the records to any     |
|                                   | other person who will accept      |
|                                   | responsibility for them under     |
|                                   | this part, including the          |
|                                   | requirements of § 812.145. Notice |
|                                   | of a transfer shall be given to   |
|                                   | FDA not later than 10 working     |
|                                   | days after transfer occurs.       |
+-----------------------------------+-----------------------------------+
| 21 CFR 312.64 Investigator        | **21 CFR 812.150 Reports.**       |
| reports.                          |                                   |
|                                   | \(a\) *Investigator reports.* An  |
| \(a\) *Progress reports.* The     | investigator shall prepare and    |
| investigator shall furnish all    | submit the following complete,    |
| reports to the sponsor of the     | accurate, and timely reports:     |
| drug who is responsible for       |                                   |
| collecting and evaluating the     | \(3\) *Progress.* An investigator |
| results obtained. The sponsor is  | shall submit progress reports on  |
| required under § 312.33 to submit | the investigation to the sponsor, |
| annual reports to FDA on the      | the monitor, and the reviewing    |
| progress of the clinical          | IRB at regular intervals, but in  |
| investigations.                   | no event less often than yearly.  |
|                                   |                                   |
| \(b\) *Safety reports.* An        | \(1\) *Unanticipated adverse      |
| investigator shall promptly       | device effects.*                  |
| report to the sponsor any adverse |                                   |
| effect that may reasonably be     | An investigator shall submit to   |
| regarded as caused by, or         | the sponsor and to the reviewing  |
| probably caused by, the drug. If  | IRB a report of any unanticipated |
| the adverse effect is alarming,   | adverse device effect occurring   |
| the investigator shall report the | during an investigation as soon   |
| adverse effect immediately.       | as possible, but in no event      |
|                                   | later than 10 working days after  |
| \(c\) *Final report.* An          | the investigator first learns of  |
| investigator shall provide the    | the effect.                       |
| sponsor with an adequate report   |                                   |
| shortly after completion of the   | \(6\) *Final report.* An          |
| investigator's participation in   | investigator shall, within 3      |
| the investigation.                | months after termination or       |
|                                   | completion of the investigation   |
| \(d\) *Financial disclosure       | or the investigator's part of the |
| reports*. The clinical            | investigation, submit a final     |
| investigator shall provide the    | report to the sponsor and the     |
| sponsor with sufficient accurate  | reviewing IRB.                    |
| financial information to allow an |                                   |
| applicant to submit complete and  | 21 CFR 812.110 Specific           |
| accurate certification or         | responsibilities of               |
| disclosure statements as required | investigators.                    |
| under part 54 of this chapter.    |                                   |
| The clinical investigator shall   | \(d\) *Financial disclosure*. A   |
| promptly update this information  | clinical investigator shall       |
| if any relevant changes occur     | disclose to the sponsor           |
| during the course of the          | sufficient accurate financial     |
| investigation and for 1 year      | information to allow the          |
| following the completion of the   | applicant to submit complete and  |
| study.                            | accurate certification or         |
|                                   | disclosure statements required    |
|                                   | under part 54 of this chapter.    |
|                                   | The investigator shall promptly   |
|                                   | update this information if any    |
|                                   | relevant changes occur during the |
|                                   | course of the investigation and   |
|                                   | for 1 year following completion   |
|                                   | of the study.                     |
|                                   |                                   |
|                                   | 21 CFR 812.150 Reports. (a)       |
|                                   | *Investigator reports* continued  |
|                                   |                                   |
|                                   | \(2\) *Withdrawal of IRB          |
|                                   | approval.* An investigator shall  |
|                                   | report to the sponsor, within 5   |
|                                   | working days, a withdrawal of     |
|                                   | approval by the reviewing IRB of  |
|                                   | the investigator's part of an     |
|                                   | investigation.                    |
|                                   |                                   |
|                                   | \(4\) *Deviations from the        |
|                                   | investigational plan*. An         |
|                                   | investigator shall notify the     |
|                                   | sponsor and the reviewing IRB     |
|                                   | (see § 56.108(a) (3) and (4)) of  |
|                                   | any deviation from the            |
|                                   | investigational plan to protect   |
|                                   | the life or physical well-being   |
|                                   | of a subject in an emergency.     |
|                                   | Such notice shall be given as     |
|                                   | soon as possible, but in no event |
|                                   | later than 5 working days after   |
|                                   | the emergency occurred. Except in |
|                                   | such an emergency, prior approval |
|                                   | by the sponsor is required for    |
|                                   | changes in or deviations from a   |
|                                   | plan, and if these changes or     |
|                                   | deviations may affect the         |
|                                   | scientific soundness of the plan  |
|                                   | or the rights, safety, or welfare |
|                                   | of human subjects, FDA and IRB in |
|                                   | accordance with § 812.35(a) also  |
|                                   | is required.                      |
|                                   |                                   |
|                                   | \(5\) *Informed consent.* If an   |
|                                   | investigator uses a device        |
|                                   | without obtaining informed        |
|                                   | consent, the investigator shall   |
|                                   | report such use to the sponsor    |
|                                   | and the reviewing IRB within 5    |
|                                   | working days after the use        |
|                                   | occurs.                           |
|                                   |                                   |
|                                   | \(7\) *Other.* An investigator    |
|                                   | shall, upon request by a          |
|                                   | reviewing IRB or FDA, provide     |
|                                   | accurate, complete, and current   |
|                                   | information about any aspect of   |
|                                   | the investigation.                |
+-----------------------------------+-----------------------------------+
| 21 CFR 312.66 Assurance of IRB    | **21 CFR** **812.60 IRB           |
| review.                           | composition, duties, and**        |
|                                   |                                   |
| An investigator shall assure that | **functions.**                    |
| an IRB that complies with the     |                                   |
| requirements set forth in part 56 | An IRB reviewing and approving    |
| will be responsible for the       | investigations under this part    |
| initial and continuing review and | shall comply with the             |
| approval of the proposed clinical | requirements of part 56 in all    |
| study. The investigator shall     | respects, including its           |
| also assure that he or she will   | composition, duties, and          |
| promptly report to the IRB all    | functions.                        |
| changes in the research activity  |                                   |
| and all unanticipated problems    | **21 CFR 812.64 IRB's continuing  |
| involving risk to human subjects  | review.**                         |
| or others, and that he or she     |                                   |
| will not make any changes in the  | The IRB shall conduct its         |
| research without IRB approval,    | continuing review of an           |
| except where necessary to         | investigation in accordance with  |
| eliminate apparent immediate      | part 56.                          |
| hazards to human subjects.        |                                   |
+-----------------------------------+-----------------------------------+
| 21 CFR 312.68 Inspection of       | **21 CFR 812.145 Inspections.**   |
| investigator's records and        |                                   |
| reports.                          | \(a\) Entry and inspection. A     |
|                                   | sponsor or an investigator who    |
| An investigator shall upon        | has authority to grant access     |
| request from any properly         | shall permit authorized FDA       |
| authorized officer or employee of | employees, at reasonable times    |
| FDA, at reasonable times, permit  | and in a reasonable manner, to    |
| such officer or employee to have  | enter and inspect any             |
| access to, and copy and verify    | establishment where devices are   |
| any records or reports made by    | held (including any establishment |
| the investigator pursuant to §    | where devices are manufactured,   |
| 312.62. The investigator is not   | processed, packed, installed,     |
| required to divulge subject names | used, or implanted or where       |
| unless the records of particular  | records of results from use of    |
| individuals require a more        | devices are kept).                |
| detailed study of the cases, or   |                                   |
| unless there is reason to believe | \(b\) Records inspection. A       |
| that the records do not represent | sponsor, IRB, or investigator, or |
| actual case studies, or do not    | any other person acting on behalf |
| represent actual results          | of such a person with respect to  |
| obtained.                         | an investigation, shall permit    |
|                                   | authorized FDA employees, at      |
|                                   | reasonable times and in a         |
|                                   | reasonable manner, to inspect and |
|                                   | copy all records relating to an   |
|                                   | investigation.                    |
|                                   |                                   |
|                                   | \(c\) *Records identifying        |
|                                   | subjects.* An investigator shall  |
|                                   | permit authorized FDA employees   |
|                                   | to inspect and copy records that  |
|                                   | identify subjects, upon notice    |
|                                   | that FDA has reason to suspect    |
|                                   | that adequate informed consent    |
|                                   | was not obtained, or that reports |
|                                   | required to be submitted by the   |
|                                   | investigator to the sponsor or    |
|                                   | IRB have not been submitted or    |
|                                   | are incomplete, inaccurate,       |
|                                   | false, or misleading.             |
+-----------------------------------+-----------------------------------+
| **21 CFR 312.69 Handling of       |                                   |
| controlled substances.**          |                                   |
|                                   |                                   |
| If the investigational drug is    |                                   |
| subject to the Controlled         |                                   |
| Substances Act, the investigator  |                                   |
| shall take adequate precautions,  |                                   |
| including storage of the          |                                   |
| investigational drug in a         |                                   |
| securely locked, substantially    |                                   |
| constructed cabinet, or other     |                                   |
| securely locked, substantially    |                                   |
| constructed enclosure, access to  |                                   |
| which is limited, to prevent      |                                   |
| theft or diversion of the         |                                   |
| substance into illegal channels   |                                   |
| of distribution.                  |                                   |
+-----------------------------------+-----------------------------------+