Sample JHM Investigator Checklist Good Clinical Practice (GCP) Guidance

Investigators should be fully aware of their obligations and responsibilities required by the JHM IRB and applicable regulatory agencies prior to conducting research. This checklist provides a su ary of investigator responsibilities pertinent to data and docu ent anage ent in accordance with !ood "linical #ractice $!"#% !uidance.

Yes

No

N!

GCP "# $%& &.'.'

Investigator 'uali(ications and !greements

(s the investigator) are you qualified by education) training) and e*perience to assu e responsibility for the proper conduct of the trial+ The investigator should eet all the qualifications specified by the applicable regulatory require ent$s%) and should provide evidence of such qualifications through up,to,date curriculu vitae and-or other relevant docu entation requested by the sponsor) the IRB-I.") and-or the regulatory authority$ies%. (s the investigator) are you thoroughly fa iliar with the appropriate use of the investigational product$s%) as described in the protocol) in the current Investigator0s Brochure) in the product infor ation) and in other infor ation sources provided by the sponsor+ (s the investigator) are you aware of !ood "linical #ractice guidance and the applicable regulatory require ents+ (s the investigator) are you aware that you regulatory authority$ies%+ (s the investigator) are you aware that you delegated significant trial,related duties+ !de*uate +esources ust per it ust onitoring and auditing by the sponsor) and inspection by the appropriate the investigator has

&.'./

&.'.1 &.'.& &.'.2

aintain a list of appropriately qualified persons to who

Yes

No

N!

GCP "# $%) &./.' &././ &./.1 &./.&

(s the investigator) are you able to de onstrate $e.g.) based on retrospective data% a potential for recruiting the required nu ber of suitable sub3ects within the agreed recruit ent period+ (s the investigator) do you have sufficient ti e to properly conduct and co plete the trial within the agreed trial period+ (s the investigator) do you have available an adequate nu ber of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely+ (s the investigator) can you ensure that all persons assisting with the trial are adequately infor ed about the protocol) the investigational product$s%) and their trial,related duties and functions+

Sample JHM Investigator Checklist , !ood "linical #ractice $!"#% !uidance

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Sample JHM Investigator Checklist Good Clinical Practice (GCP) Guidance

Yes

No

N!

GCP "# $%&.1.' &.1./

Medical Care o( .rial Su/0ects

(s the investigator) can you ensure a qualified physician $or dentist) when appropriate%) either yourself or a sub,investigator for the trial) will be responsible for all trial,related edical $or dental% decisions+ (s the investigator) can you ensure that adequate edical care is provided to a sub3ect for any adverse events $including clinically significant laboratory values% related to the trial) both during and following a sub3ect0s participation in a trial+ The investigator should infor a sub3ect when edical care is needed for intercurrent illness$es% of which the investigator beco es aware. (s the investigator) will you infor the sub3ect0s pri ary physician about the sub3ect0s participation in the trial if the sub3ect has a pri ary physician and if the sub3ect agrees to the pri ary physician being infor ed+ (lthough a sub3ect is not obliged to give his-her reason$s% for withdrawing pre aturely fro a reasonable effort to ascertain the reason$s%) while fully respecting the sub3ect0s rights+ Communication 1ith the I+2 a trial) as the investigator) will you ake

&.1.1 &.1.&

Yes

No

N!

GCP "# $%$ &.&.'

(s the investigator) do you have written and dated approval fro the IRB for the research application) written infor ed consent for ) consent for updates) sub3ect recruit ent procedures $e.g.) advertise ents%) and any other written infor ation to be provided to sub3ects+ (s the investigator) did you provide the IRB with a current copy of the Investigator0s Brochure+ If the Investigator0s Brochure is updated during the trial) you ust provide a copy of the updated Investigator0s Brochure to the IRB. (s the investigator) did you provide the IRB with all docu ents sub3ect to review according to the IRB4s require ents+ Compliance 1ith the I+2,!pproved +esearch !pplication

&.&./ &.&.1 Yes No N! GCP "# $%3 &.2.' &.2./

(s the investigator) will you conduct the research in co pliance with the research application that was given approval by the IRB+ (s the investigator) you ust sign the research application to confir agree ent. (s the investigator) can you ensure that you will not i ple ent any deviation fro the IRB,approved research application without prior review and docu ented approval fro the IRB of a odification+ If necessary to eli inate an i ediate ha5ard to research sub3ects) a investigator ay deviate fro the IRB,approved research application without prospective IRB approval. (s the investigator) will you docu ent and e*plain any deviation fro approval+ the approved protocol that occurs without prospective IRB

&.2.1

Sample JHM Investigator Checklist , !ood "linical #ractice $!"#% !uidance

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Sample JHM Investigator Checklist Good Clinical Practice (GCP) Guidance

&.2.&

(s the investigator) if you deviate fro the IRB,approved research application to eli inate an i ediate ha5ard$s% to research sub3ects without prospective IRB approval) will you sub it a odification and e*plain the deviation to the IRB+

Yes

No

N!

GCP "# $%# &.6.' &.6./ &.6.1

Investigational Product(s)

(s the investigator) will you take responsibility for investigational product$s% accountability at the research site$s%+ (s the investigator) will you assign so e or all of your duties for investigational product$s% accountability at the research site$s% to an appropriate phar acist or another appropriate individual who is under your supervision+ (s the investigator) will you) or a designee you have appointed) aintain records of the product0s delivery to the research site) the inventory at the site) the use by each sub3ect) and the return to the sponsor or alternative disposition of unused product$s%+ These records should include dates) quantities) batch-serial nu bers) e*piration dates $if applicable%) and the unique code nu bers assigned to the investigational product$s% and research sub3ects. Investigators should aintain records that docu ent adequately that the sub3ects were provided the doses specified by the protocol and reconcile all investigational product$s% received fro the sponsor. (s the investigator) will you ensure that the investigational product$s% will be stored as specified by the sponsor and in accordance with applicable regulatory require ent$s%+ (s the investigator) will you ensure that the investigational product$s% are used only in accordance with the IRB,approved research application+ (s the investigator) will you) or a designee you have appointed) e*plain the correct use of the investigational product$s% to each sub3ect+ 7ill you) or a designee you have appointed) periodically check that each sub3ect is following the instructions properly+ +andomi5ation Procedures and 6n/linding

&.6.& &.6.2 &.6.6

Yes

No

N!

GCP "# $%4

(s the investigator) will you follow the trial0s rando i5ation procedures) if any+ 7ill you ensure that the code is broken only in accordance with the IRB,approved research application+ If the research is blinded) will you pro ptly docu ent and e*plain to the sponsor any pre ature unblinding $e.g.) accidental unblinding) unblinding due to a serious adverse event% of the investigational product$s%+

Sample JHM Investigator Checklist , !ood "linical #ractice $!"#% !uidance

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Sample JHM Investigator Checklist Good Clinical Practice (GCP) Guidance

Yes

No

N!

GCP "# $%7 &.8.'

In(ormed Consent o( .rial Su/0ects

(s the investigator) will you co ply with the applicable regulatory require ent$s% and adhere to !"# and to the ethical principles that have their origin in the 9eclaration of Helsinki in obtaining and docu enting infor ed consent+ #rior to the beginning of the research study) the investigator ust have the IRB0s written approval of the written infor ed consent for and any other written infor ation to be provided to sub3ects. (s the investigator) will you ensure that the written infor ed consent for and any other written infor ation to be provided to sub3ects will be revised whenever i portant new infor ation beco es available that ay be relevant to the sub3ect0s consent+ (ny revised consent for and other written infor ation provided to sub3ects ust receive the IRB4s approval in advance of use. The sub3ect or the sub3ect0s legally acceptable representative should be infor ed in a ti ely anner if new infor ation beco es available that ay be relevant to the sub3ect0s willingness to continue participation in the research) and the co unication of this infor ation should be docu ented. (s the investigator) will you ensure that neither you nor the research staff will coerce or unduly influence a sub3ect to participate or to continue to participate in the research+ (s the investigator) will you ensure that none of the oral and written infor ation concerning the trial) including the written infor ed consent for ) contains any language that causes the sub3ect or the sub3ect0s legally acceptable representative to waive or to appear to waive any legal rights) or that releases or appears to release the investigator) the institution) the sponsor) or their agents fro liability for negligence+ (s the investigator) will you ensure that you) or a designee you have appointed) will fully infor the sub3ect or) if the sub3ect is unable to provide infor ed consent) the sub3ect0s legally acceptable representative) of all pertinent aspects of the research including the written infor ation and the approval by the IRB+ (s the investigator) will you ensure that the language used in the oral and written infor ation about the research) including the consent for ) will be as non,technical as practical and will be understandable to the sub3ect or the sub3ect0s legally acceptable representative and the i partial witness) where applicable+ (s the investigator) will you ensure that you) or a designee you have appointed) will provide the sub3ect or the sub3ect0s legally acceptable representative a ple ti e and opportunity to inquire about details of the trial and to decide whether or not to participate in the research+ (ll questions about the trial should be answered to the satisfaction of the sub3ect or the sub3ect0s legally acceptable representative. (s the investigator) will you ensure that the written consent for is signed and personally dated by the sub3ect or by the sub3ect0s legally acceptable representative) and by the person who conducted the infor ed consent discussion prior to a sub3ect0s participation in any research procedures+

&.8./

&.8.1 &.8.&

&.8.2

&.8.6

&.8.:

&.8.8

Sample JHM Investigator Checklist , !ood "linical #ractice $!"#% !uidance

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Sample JHM Investigator Checklist Good Clinical Practice (GCP) Guidance

&.8.;

(s the investigator) will you ensure that) if a sub3ect is unable to read or if a legally acceptable representative is unable to read) an i partial witness will be present during the entire infor ed consent discussion+ (fter the written infor ed consent for ) and any other written infor ation to be provided to sub3ects) is read and e*plained to the sub3ect or the sub3ect0s legally acceptable representative) and after the sub3ect or the sub3ect0s legally acceptable representative has orally consented to the sub3ect0s participation in the trial and) if capable of doing so) has signed and personally dated the infor ed consent for ) the witness should sign and personally date the consent for . By signing the consent for ) the witness attests that the infor ation in the consent for and any other written infor ation was accurately e*plained to) and apparently understood by) the sub3ect or the sub3ect0s legally acceptable representative) and that infor ed consent was freely given by the sub3ect or the sub3ect0s legally acceptable representative. (s the investigator) will you ensure that) the infor ed consent discussion and the written infor ed consent for and any other written infor ation to be provided to sub3ects should include e*planations of the following= That the trail involves research. The purpose of the trial. The trial treat ent$s% and probability for rando assign ent to each treat ent. The trail procedures to be followed) including all invasive procedures. The sub3ect4s responsibilities. Those aspects of the trial that are e*peri ental. The reasonably foreseeable risks or inconveniences to the sub3ect and) when applicable) to an e bryo) fetus) or nursing infant. The alternative procedure$s% or course$s% of treat ent that ay be available to the sub3ect) and their i portant potential benefits and risks. The co pensation and-or treat ent available to the sub3ect in the event of trial,related in3ury. The anticipated prorated pay ent) if any) to the sub3ect for participating in the trial. The anticipated e*penses) if any) to the sub3ect for participating in the trial. That the sub3ect0s participation in the trial is voluntary and that the sub3ect ay refuse to participate or withdraw fro the trial) at any ti e) without penalty or loss of benefits to which the sub3ect is otherwise entitled. That the onitor$s%) the auditor$s%) the IRB-I.") and the regulatory authority$ies% will be granted direct access to the sub3ect0s original edical records for verification of clinical trial procedures and-or data) without violating the confidentiality of the sub3ect) to the e*tent per itted by the applicable laws and regulations and that) by signing a written infor ed consent for ) the sub3ect or the sub3ect0s legally acceptable representative is authori5ing such access. That records identifying the sub3ect will be kept confidential and) to the e*tent per itted by the applicable laws and-or regulations) will not be ade publicly available. If the results of the trial are published) the sub3ect4s identity will re ain confidential. That the sub3ect or the sub3ect0s legally acceptable representative will be infor ed in a ti ely anner if infor ation beco es available that ay be relevant to the sub3ect0s willingness to continue participation in the trial. The person$s% to contact for further infor ation regarding the trial and the rights of trial sub3ects) and who to contact in the Page 5 of 8

&.8.'<

Sample JHM Investigator Checklist , !ood "linical #ractice $!"#% !uidance

Sample JHM Investigator Checklist Good Clinical Practice (GCP) Guidance

event of trial,related in3ury. The foreseeable circu stances and-or reasons under which the sub3ect0s participation in the trial The e*pected duration of the sub3ect0s participation in the trial. The appro*i ate nu ber of sub3ects involved in the trial.

&.8.''

ay be ter inated.

(s the investigator) will you ensure that) prior to participation in the research) the sub3ect or the sub3ect0s legally acceptable representative will receive a copy of the signed and dated consent for and any other written infor ation provided to the sub3ect. 9uring a sub3ect0s participation in the research) the sub3ect or the sub3ect0s legally acceptable representative should receive a copy of the signed and dated revised consent for and a copy of any updates to the written infor ation provided to sub3ects. (s the investigator) will you ensure that when research $therapeutic or non,therapeutic% includes sub3ects who can only be enrolled in the research with the consent of the sub3ect0s legally acceptable representative $e.g.) inors) or patients with severe de entia%) the sub3ect will be infor ed about the research to the e*tent co patible with the sub3ect0s understanding and) if capable) the sub3ect will be given the opportunity to sign and personally date the written infor ed consent+ (s the investigator) will you ensure that) e*cept as described in &.8.'& $below%) non,therapeutic research $i.e.) research in which there is no anticipated direct clinical benefit to the sub3ect%) will be conducted in sub3ects who personally give consent and who sign and date the written infor ed consent for + >on,therapeutic research ay be conducted in sub3ects with consent of a legally acceptable representative provided the following conditions are fulfilled= The ob3ectives of the research can not be et by eans of research in sub3ects who can give infor ed consent personally. The foreseeable risks to the sub3ects are low. The negative i pact on the sub3ect0s well,being is The research is not prohibited by law. ini i5ed and low.

&.8.'/

&.8.'1

&.8.'&

The approval of the IRB is e*pressly sought on the inclusion of such sub3ects) and the IRB4s written approval covers this aspect. ?uch research) unless an e*ception is 3ustified) should be conducted in patients having a disease or condition for which the investigational product is intended. ?ub3ects in these studies should be particularly closely onitored and should be withdrawn if they appear to be unduly distressed. &.8.'2 (s the investigator) will you ensure that in e ergency situations) when prior consent of the sub3ect is not possible) the consent of the sub3ect0s legally acceptable representative) if present) will be requested+ 7hen prior consent of the sub3ect is not possible) and the sub3ect0s legally acceptable representative is not available) enroll ent of the sub3ect requires easures described in the research application and-or elsewhere) with docu ented IRB approval to protect the rights) safety) and well,being of the sub3ect and to ensure co pliance with applicable regulatory require ents. The sub3ect or the sub3ect0s legally acceptable representative ust be infor ed about the research as soon as possible and consent to continue and other consent as appropriate $see &.8.'< above% should be requested.

Sample JHM Investigator Checklist , !ood "linical #ractice $!"#% !uidance

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Sample JHM Investigator Checklist Good Clinical Practice (GCP) Guidance

Yes

No

N!

GCP "# $%8 &.;.' &.;./ &.;.1

+ecords and +eports (s the investigator) will you ensure the accuracy) co pleteness) legibility) and ti eliness of the data reported to the sponsor in the "R@s and in all required reports+ (s the investigator) will you ensure that data reported on the "R@ derived fro docu ents+ If there are any discrepancies) they should be e*plained. source docu ents are consistent with the source

(s the investigator) will you ensure that any change or correction to a "R@ will be dated) initialed) and e*plained $if necessary% and will not obscure the original entry $i.e.) an audit trail should be aintained%+ This applies to both written and electronic changes or corrections. ?ponsors should provide guidance to investigators and-or the investigators0 designated representatives on aking such corrections. ?ponsors should have written procedures to assure that changes or corrections in "R@s ade by sponsor0s designated representatives are docu ented) are necessary) and are endorsed by the investigator. (s the investigator) you should retain records of the changes and corrections. (s the investigator) will you aintain the research docu ents as required by the applicable regulatory require ent$s%+ The investigator should take easures to prevent accidental or pre ature destruction of these docu ents. (s the investigator) will you ensure that essential docu ents will be retained until at least / years have elapsed since the for al discontinuation of clinical develop ent of the investigational product+ If required by the applicable regulatory require ents or by an agree ent with the sponsor) these docu ents ay need to be retained for a longer period. It is the sponsor4s responsibility to infor the investigator as to when these docu ents no longer need to be retained. (s the investigator) will you ensure that the financial aspects of the study are docu ented in an agree ent between yourself and the sponsor+ (s the investigator) will you ake available for direct access all requested research,related records upon request of the auditor) IRB) or regulatory authority+ Progress +eports onitor)

&.;.& &.;.2

&.;.6 &.;.:

Yes

No

N!

GCP "# $%&9 &.'<.' &.'<./

(s the investigator) will you sub it written su the IRB+

aries of the research status to the IRB annually) or

ore frequently if requested by

(s the investigator) will you pro ptly provide written reports to the sponsor) the IRB and) where applicable) the institution on any changes significantly affecting the conduct of the research) and-or increasing risks to sub3ects+

Sample JHM Investigator Checklist , !ood "linical #ractice $!"#% !uidance

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Sample JHM Investigator Checklist Good Clinical Practice (GCP) Guidance

Yes

No

N!

GCP "# $%&& &.''.'

Sa(et: +eporting

(s the investigator) will you i ediately report all serious adverse events $?(.s% to the sponsor) e*cept for those ?(.s that the protocol or other docu ent $e.g.) Investigator0s Brochure% identifies as not needing i ediate reporting+ The i ediate reports should be followed pro ptly by detailed) written reports. The i ediate and follow,up reports should identify sub3ects by unique code nu bers assigned to the research sub3ects rather than by the sub3ects0 na es) personal identification nu bers) and-or addresses. (s the investigator) you should also co ply with the applicable regulatory require ent$s% related to the reporting of une*pected serious adverse drug reactions to the IRB and regulatory authority$ies%. (s the investigator) will you report adverse events and-or laboratory abnor alities identified in the protocol as critical to safety evaluations to the sponsor according to the reporting require ents and within the ti e periods specified by the sponsor in the protocol+ (s the investigator) will you supply the sponsor and the IRB with any additional requested infor ation for reported deaths $e.g.) autopsy reports and ter inal edical reports%+ Premature .ermination or Suspension o( a .rial

&.''./

&.''.1

Yes

No

N!

GCP "# $%&)

(s the investigator) if the trial is pre aturely ter inated or suspended for any reason) will you pro ptly infor the trial sub3ects) assure appropriate therapy and follow,up for the sub3ects) and) where required by the applicable regulatory require ent$s%) infor the regulatory authority$ies%+ &.'/.' (s the investigator) if you ter inate or suspend research without prior agree ent of the sponsor) will you infor the sponsor and the IRB+ The investigator should provide the sponsor and the IRB with a detailed written e*planation of the ter ination or suspension. If the sponsor ter inates or suspends a trial) as the investigator) will you pro ptly infor e*planation of the ter ination or suspension+ the IRB and provide a detailed written

&.'/./ &.'/.1

If the IRB ter inates or suspends its approval of your research) will you notify the sponsor and provide the sponsor with a detailed written e*planation of the ter ination or suspension+ ;inal +eport(s) /: Investigator

Yes

No

N!

GCP "# $%&-

Apon co pletion of the research) as the investigator) will you infor provide any reports required by the regulatory authority$ies%+

the IRB and provide a su

ary of the research results) and

Sample JHM Investigator Checklist , !ood "linical #ractice $!"#% !uidance

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